AstraZeneca to strengthen therapy area franchise through acquisition of Takeda's respiratory business

AstraZeneca today announced that it has entered into a definitive agreement to acquire the core respiratory business of Takeda Pharmaceutical Company Limited ("Takeda"). The deal will include the expansion of rights to roflumilast (marketed as Daliresp in the US and Daxas in other countries), the only approved oral PDE4 inhibitor for the treatment of chronic obstructive pulmonary disease (COPD).
AstraZeneca has marketed Daliresp in the US since the acquisition of the rights from Actavis in the first quarter of 2015. Full acquisition of the global rights will support AstraZeneca's respiratory franchise and complement the company's portfolio of treatments for severe COPD. Recent data(1) reinforce the benefit Daxas brings to patients in reducing exacerbations as an add-on to dual and free-triple(2) inhaled combination therapies. The agreement will also provide AstraZeneca with access to other marketed respiratory medicines and early pipeline products.
Under the terms of the agreement, AstraZeneca will make a payment of $575 million. Approximately 200 staff will transfer to AstraZeneca upon completion.
Luke Miels, Executive Vice President Global Portfolio and Product Strategy at AstraZeneca, said: "The agreement with Takeda complements our respiratory business, one of our three main therapy areas, supports our return to growth and will be immediately accretive to earnings from 2016. Daxas in particular adds to our portfolio of treatments for patients with severe COPD."
Annual global sales of the three core medicines acquired, excluding any AstraZeneca sales of Daliresp in the US(3), were $198 million for the period ending in March 2015. The transaction will be accounted for as a business combination and is expected to close during the first quarter of 2016, subject to customary closing conditions. It is expected to be immediately accretive to earnings from 2016. The acquisition of global rights to Daliresp will also negate the Company's existing royalty payments for the medicine in the US. Full Year 2016 guidance is expected to be provided at Full Year 2015 results on 4 February 2016.

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2. 42, 3- Dimethyl-4- Nitro Pyridine- N-Oxide
3. 3,5 Dimethyl -4-Nitro Pyridine-N-Oxide Omeprazole
4.3,5-Bis-(Di bromo methyl ) toluene Anastrazole
5.4-Bromo benzyl cyanide
6.4-BromoPhenyl acetic acid Bilastin
7.4-Methoxy-3-sulfamoylPhenyl acetone Tamsulosin
8.4-Nitro Pyridine N-Oxide
9.6-Nitro Veratric acid
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3. 4-Acetamido-2-methylbenzonitrile
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6. 4-Amino-3-nitrobenzoic acid
7. 4-Amino-3,5-dichlorobenzoic acid
8. 4-Bromo Guaiacol
9. 4-Bromo-2-chloroaniline
10. 4-bromo-2-ethylphenol [
11. 4-Bromo-2-methylbenzoic acid
12. 4-Bromo-m-toluic acid (COOH=1)
13. 4-Bromophenetole
14. 4-Chloro-3-nitroacetophenone
15.4-chloroquinolin-2(1H)-one
16.4-Fluoroisoquinoline
17.4-Hydroxy quinolone
18.4-Hydroxybenzoic acid hydrazide
19.4-Hydroxybutanoate
20.4-Iodoaniline …
21.4-Iodobenzoic acid
22.4-Methoxy-3-nitrobenzoic acid
23.4-methoxybutyric acid
24.4-Methyl-3-nitrobenzoic acid
25.4-Nitro-3-Picoline-N-oxide
26.4-Phenyl-1-butanol
27.4-Picoline-N-oxide
28.4-Pyrimidone
29.4'-Bromo-2'-methylacetophenone
30.5-Bromo-quinoline
31.5-bromoquinolin-8-ol
32.5-Chloro-6-hydroxynicotinic Acid …
33.5-Fluoro-2-methylindole
34.5-Nitro Barbuturic acid
35.6-Bromooxindole
36.6-bromoquinoline
37.6-chloro-5H-purine
38.6-Chloronicotinic acid
39.6-Chloronicotinonitrile
40.6-Hydroxynicotinic acid
41.6-methyl-quinolin
42.6-Nitroquinoline
43.7-Azaindole
44.7-bromoindole
45.7-Hydroxy-4-methylcoumarin
46.7-methoxy-1-tetralone
47.8-Nitroquinoline
48.Alpha-Methylcinnamic acid
49.benzyl formate
50.dibenzo(d,e,f,p)chrysene
51.dimethyl furan-2,5-dicarboxylate
52.Ethanone,1-(4-amino-2-methylphenyl)-
53.Ethyl 3-bromobenzoate
54.Ethyl 3,4-dihydroxybenzoate
55.Ethyl 5-methylindole-2-carboxylate
56.Ethyl 6-chloronicotinate
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58.furan-2,5-dicarboxylic acid …
59.Hypoxanthine …Read more
60.Indeno(1,2,3-cd)pyrene
61.Indole-2-carboxylic acid
62.Methacryloyl chloride …
63.Methanesulphonylacetic acid
64.Methyl 6-chloronicotinate …
65.Mucobromic acid …Read more
66.Nitrophenylenediaminemonohydrochloride
67.p-[(p-aminophenyl)azo]benzoic acid …
68.pent-2-yn-1-ol …
69.Quinoline-N-oxide hydrate …
70.Quinoline-N-oxide hydrate …
71.R-3-Aminohexahydro-2H-azepin-2-one hydrochloride
72.Rosuvastatin Calcium

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Dr Reddy's crossed Rs.4000 mark on BSE with 86% income from exports, new launches

Dr Reddy's Laboratories (DRL), the second largest pharmaceutical company in India after Sun Pharmaceutical Industries, is surging ahead with strong domestic sales as well as exports to overseas markets with clear focus on research and development, expansion, alliances and new products. After good financial performance in the first quarter ended June 2015 as well as for full year 2014-15, DRL scrip moved up strongly and touched its yearly high level at Rs.4084.95 with full market capitalization of over Rs.68,550 crore on the BSE. With 25.5 per cent equity holding with promoters and 37.8 per cent by foreign institutional investors, DRL share of Rs.5 each is crossed milestone of Rs.4000 on July 31, 2015.

Considering the changing healthcare scenario, DRL has changed its corporate brand identity recently with new logo which is an expression of empathy and dynamism. The new logo keeps patients at the center of everything that DRL does. The objective of the re-branding exercise is to derive a unifying, patient-centric approach, to meet new and daunting challenges that patients are facing.

DRL has posted satisfactory financial performance during the first quarter ended June 2015. Its consolidated net profit went up by 13.7 per cent to Rs.626 crore from Rs.550 crore in the corresponding period of last year. EBITDA improved by 12 per cent to Rs.990 crore. Its consolidated net sales increased by 6.8 per cent to Rs.3,758 crore from Rs.3,518 crore. EPS improved to Rs.36.71 from Rs.32.34 in the last period.

Pantheon buys Italian-based clinical engineering service provider IBSL

Pantheon Holdco Ltd., doing business as the Pantheon Healthcare Group (Pantheon), has acquired Ingegneria Biomedica Santa Lucia S.p.A. (IBSL), a key Italy-based provider of clinical engineering and a large range of biomedical equipment services, from Gruppo Giglio.

Backed by the Permira Funds, the acquisition is part of Pantheon's continued geographic and modality growth strategy, which launched in August 2014 with the acquisition of Asteral Limited and MESA Group Holdings, two leading independent healthcare service companies operating within the European market. The combination created Europe's first integrated multi-vendor healthcare service platform for procuring, commissioning, managing and maintaining biomedical devices and diagnostic imaging equipment within public- and private-sector hospitals and clinics.

IBSL was born in 1997 from the entrepreneurial idea of Sergio and Bruno Giglio's long customer-centric experience with outsourcing options for heating systems. Their biomedical business quickly grew to become one of the leading clinical engineering service providers in Italy, providing direct maintenance to biomedical systems within hospitals and clinics across Italy. In the ensuing years, IBSL integrated further management expertise and technical competences through the acquisition of D&D Med. Com., Ra.se.co, Gidea Alta Tecnologia and Te.Mo.Sa, further strengthening its position in clinical engineering and expanding its reach in the sector of diagnostic imaging equipment and outsourcing services.

Novartis swaps three mid stage clinical assets with Mereo BioPharma

Novartis, a global healthcare company, announced a swap of clinical assets for equity with Mereo BioPharma Group Ltd. The deal involves compounds in areas of unmet medical need including BPS-804, to improve bone density in brittle bone syndrome, an orphan disease; BCT-197 for acute exacerbations in COPD, and BGS-649 for obese men with hypogonadotrophic hypogonadism to normalize testosterone levels.

Under the terms of the agreement, Novartis will have an equity stake in Mereo and will share in the success of the development of these compounds, including a share on milestones and royalties on future commercial sales.

Merck net profit dips by 66% to $688 million in Q2

Merck has received major setback during the second quarter ended June 2015 due to acquisitions, divestitures and foreign exchange. Its net profit declined sharply by 66 per cent to $687 million from $2,004 million in the corresponding period of last year. Its sales also declined by 11 per cent to $9,785 million from $10,934 million on account of lower sales in cardiovascular and hepatitis C portfolios. With lower profit, its EPS declined to $0.24 from $0.68 in the last period. R&D expenditure increased slightly to $1,670 million from $1,664 million.

Kenneth C Frazier, chairman and chief executive officer, said, “We're investing resources to grow our strongest brands and to support the most promising assets in our pipeline, while at the same time lowering our cost base and delivering operation leverage. We have made significant progress this quarter in two of our most important assets, the Keytruda and hepatitis C programmes, and will be fully prepared to take advantage of these potentially breakthrough opportunities. We are witnessing the introduction of breakthrough therapies for some of the most difficult-to-treat diseases.”

Its pharmaceutical sales declined by 6 per cent to $8,564 million from $9,098 million and that of animal health by 4 per cent to $840 million from $872 million. The company divested its consumer care business. The sales of cardiovascular portfolio of Zetia and Vytorin in US declined due to loss of exclusivity and that of Remicade, a treatment for inflammatory diseases, due to loss of exclusivity in Europe. Zetia sales declined $635 million from $717 million and that of Vytorin went down to $320 million from $417 million. Remicade sales declined to $455 million from $607 million.

Genzyme to buy AstraZeneca's rare disease medicine Caprelsa for $300 million

AstraZeneca, a global, innovation-driven biopharmaceutical business, has entered into a definitive agreement with Genzyme to divest Caprelsa (vandetanib), a rare disease medicine.

Caprelsa was granted Orphan Drug Designation by the US FDA in 2005 and is currently available in 28 countries for the treatment of aggressive and symptomatic medullary thyroid carcinoma, with global product sales of $48 million in 2014.

Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300 million, including an upfront payment of $165 million to acquire the global rights to sell and develop Caprelsa, and further development and sales milestone payments of up to $135 million. The transaction does not include the transfer of any AstraZeneca employees or facilities. As an asset divestment, upfront receipt and any subsequent payments will be reported in Other Operating Income in the company’s financial statements.

Luke Miels, executive vice president, global product & portfolio strategy and corporate affairs, AstraZeneca, said: “Caprelsa is a rare disease therapy and the divestment to Genzyme, an expert leader in endocrinology, demonstrates our commitment to ensure patients continue to have access to this medicine while we sharpen our focus on key disease areas.”

Yara and BASF to set up $600-mn ammonia plant in Texas

Norwegian firm Yara International ASA and Germany-based BASF have agreed to set up an ammonia plant at the BASF site in Freeport, Texas, involving an investment of $ 600 million. As part of the project, Yara will build an ammonia tank at the BASF terminal and BASF will upgrade its current terminal and pipeline assets for the export of ammonia from the new plant - which is expected to come online in 2017.
 
"I am very pleased to be here today, initiating the construction of an important investment for Yara - alongside our partners at BASF. The building of the Freeport ammonia plant is a firm demonstration of how we deliver on our growth strategy," said Torgeir Kvidal, president and CEO of Yara, while attending groundbreaking ceremony for the new ammonia plant.

The plant will have a capacity of about 750,000 metric tonnes per year and will be owned 68 percent by Yara and 32 percent by BASF. Each party will off-take ammonia from the plant in accordance with its equity share. BASF will use its share of ammonia from the plant to produce caprolactam, a key ingredient in the manufacture of nylons for carpet, textiles, film, monofilaments, and wire and cable. Yara will market the remainder mostly to industrial customers in North America, in addition to supplying the agricultural sector.

Chimerix reports positive results from brincidofovir study

Chimerix, Inc., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced that its investigational antiviral brincidofovir showed a survival benefit in a pivotal study of an animal model for smallpox.

Chimerix is developing brincidofovir as a medical countermeasure against smallpox, for which there is no antiviral agent currently approved. Brincidofovir has demonstrated broad-spectrum in vitro activity across five families of DNA viruses, and in addition to smallpox, is also being studied in two phase 3 clinical trials for prevention of cytomegalovirus (CMV) and treatment of adenovirus infections in immunocompromised patients. The US Food and Drug Administration (FDA) has granted Fast Track status to brincidofovir for smallpox, CMV, and adenovirus.

The pivotal smallpox study was conducted under the FDA's Animal Efficacy Rule, which allows for testing of investigational compounds in animal models to support the drug's effectiveness in diseases which are not ethical or feasible to study in humans. The primary objective of this study was to assess the efficacy of immediate and delayed treatment with brincidofovir after clinical signs of disease compared with placebo in preventing mortality in rabbits infected with the lethal rabbitpox virus - a well-characterized model of smallpox. The study met its primary endpoint.

Rabbits treated with brincidofovir upon the first clinical sign of disease, and rabbits that received brincidofovir 24 or 48 hours after the first clinical sign of disease, demonstrated a statistically significant (p < 0.05) reduction in mortality compared to rabbits that received placebo. Final results from this study, including data on the incidence and severity of clinical and laboratory events in each cohort, are expected by the fourth quarter of 2015 and will be submitted to an upcoming medical conference and to the FDA for discussion of next steps.

Sigma-Aldrich receives ISO 13485 certification

Sigma-Aldrich Corporation, a leading life science and high technology company, has received ISO 13485 certification for expanded quality assurance capabilities at its Dekalb and Barton facilities located in St. Louis.

The certification extends Sigma-Aldrich's ability to manufacture and offer critical raw materials, such as enzymes, proteins and antibodies used in diagnostic assays, and provides in vitro diagnostic (IVD) customers with industry-leading assurance of consistent quality to meet and exceed their supply chain needs at a time of increased regulatory requirements.

The Dekalb site, which manufactures enzymes and proteins, achieved the ISO 13485 certification following significant investments in production and packaging facilities as well as personnel training. A similar commitment to invest in capabilities for the diagnostics customer segment enabled ISO 13485 certification of quality management systems at the state-of-the-art Barton distribution warehouse, that can now serve as a central North American distribution center for Sigma-Aldrich raw materials designed for use in IVD manufacturing applications. These two St. Louis-based sites join the growing roster of ISO 13485 certified facilities located in Jerusalem and Rehovot (Israel, obtained in Q4 of 2014), which manufacture antibodies and enzymes, as well as the St. Louis Ewing site, which provides OEM assay manufacturing services to diagnostic customers.

As one of the leading suppliers of raw materials to the diagnostic market, Sigma-Aldrich made an investment to extend its ISO 13485 certification based on the company's assessment of clients' current and future needs. Sigma-Aldrich continually invests in quality assurance initiatives and has 44 Quality Control laboratories worldwide, as well as approximately 800 employees within the Sigma-Aldrich Quality organisation.

Pfizer plans to close its 50-year old Thane facility in September

Pfizer, a Rs. 1,800 crore plus pharma MNC after merging Wyeth, has decided to shut down its over 50 years Thane facility from September 16, 2015. The decision to close the site is based on an assessment its long term viability and its ability to achieve the needed production. There has practically been no production activity at this plant since 2013, and the closure will not impact the supply of any of our medicines to patients.

The company had offered a generous voluntary retirement scheme (VRS) to the workmen at this site last year, upon their request. This was taken up by as many as 132 of the 212 workmen. The remaining 80 workmen have continued to receive full wages, despite plant inactivity. As a part of the closure process, the company will honour its obligations towards requisite compensation, as mandated by law, for the remaining workmen. We are grateful for the contribution of the workmen and colleagues and will ensure that they are treated with fairness and respect.

Pfizer remains committed to providing high quality medicines to our patients and customers in India.

Dr Reddy's launches OTC hair care drug Hairootz

Hairootz comes from the same branch of business that markets Mintop, a solution used for prevention of hair loss.
 
Studies reveal that more than 58 percent of men aged 30-50 years suffer from a common type of hair loss, due to modern lifestyles which has brought about various nutrition related deficiencies and diseases, hair loss being one of them. Hairootz provides key nutrients needed for maintaining healthy hair. Stressful lifestyles often lead to hair greying and hair loss.
 
“Hairootz’s unique formula has grape seed extract containing potent antioxidants, which are 20 times greater than vitamins E & C 2. Other key ingredients include Biotin which helps prevent excessive hair loss, minerals which have shown to reduce hair thinning, breakage and prevent dandruff and greying. It also includes key amino acids which would promote hair growth by improved blood circulation to hair roots,” said Dr Reddy’s in a press release.

Syngene gets FIPB approval with foreign investment limit to 44%

Syngene International, one of the leading India-based Contract Research Organisation (CRO) and a subsidiary of Biocon Ltd, has received the Foreign Investment Promotion Board (FIPB) approval for raising the foreign investment to 44 per cent from the earlier approved 10 per cent by way of its Initial Public Offering (IPO).

Commenting on the development, Peter Bains, chief executive officer, Syngene International, said, “We are happy to receive the FIPB approval to increase the foreign investment limit in our company. Syngene supports the global pharmaceutical, biotech and life science industries; this approval will enable us to look to broaden our global investor base.”

The IPO is an offer for sale (OFS) by Biocon of a part of its shareholding in Syngene. The Biocon Group presently holds 83.6 per cent equity stake in Syngene.

Syngene reported revenues of Rs. 7,077 million for FY 2013-14 and Rs. 6,175 million for 9 month ended December 31, 2014. For the three fiscal years ended March 31, 2014, its total revenue, restated profit and EBITDA grew at compounded annual growth rates (CAGR) of 29.9 per cent, 70.5 per cent and 30.6 per cent, respectively. Its flexible business models, expertise in managing large integrated collaborations and world-class infrastructure has not only helped it renew and expand its existing client collaborations but also in attracting new clients. Syngene’s client base increased 90 per cent from 103 in FY 2012 to 195 as on December 31, 2014.

Jubilant Life Sciences' levofloxacin tablets receives ANDA approval

Jubilant Life Sciences Ltd, an integrated global pharmaceuticals and life sciences company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for levofloxacin tablets, 250mg and 500mg.

Levofloxacin tablets, the generic version of Levaquin tablets of Ortho-McNeil, is used for the treatment of adults with infections such as pneumonia, bacterial sinusitis, chronic bronchitis, skin and skin structure infections, chronic bacterial prostatitis, urinary tract infections and inhalational anthrax. The total market size for Levofloxacin tablets as per IMS is $28 million per annum.

As on March 31, 2015, Jubilant Life Sciences had a total of 806 filings for formulations of which 368 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 Dossier filings in Europe.

The company is engaged in manufacture and supply of APIs, solid dosage formulations, specialty pharmaceuticals and life science ingredients. It also provides services in contract manufacturing and drug discovery solutions.

D-Pharm announces positive phase 2 study results of THR-18 in acute stroke patients

D-Pharm Ltd., a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders, has received the final report for its phase 2 clinical study of THR-18. THR-18 demonstrated statistically significant reductions in the incidence of intracranial hemorrhage (ICH), brain swelling (edema) and a satisfactory safety profile in stroke patients treated with tPA. Moreover, stroke recovery was improved 2-fold in patients receiving THR-18, as judged by clinical outcome measures, 30 days following stroke.

THR-18 is a novel drug-candidate designed to neutralize or reduce the life-threatening adverse effects of thrombolytic therapy with tPA. This double-blind, placebo-controlled, escalating single-dose, Phase 2 study was the first to assess the safety, pharmacodynamics and pharmacokinetics of THR-18 and tPA in AIS patients. The study results were presented last month at the European Stroke Organization conference in Glasgow.

The study successfully defined the maximal tolerated and safe dose of THR-18 in AIS patients. The imaging data as assessed by CT (computed tomography) on day 2 following stroke and tPA treatment indicate that, in contrast to the placebo group, no patients treated with THR-18 had an intracranial hemorrhage, (p=0.02). Similarly, 0.54 mg/kg of THR-18 reduced by more than twice the occurrence of brain edema (p<0.05). 

Iroko Pharma receives US patent for Zorvolex

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has received patent from the United States Patent and Trademark Office (USPTO) for the composition of matter covering Zorvolex (diclofenac) capsules 18 mg or 35 mg to treat mild to moderate acute pain and osteoarthritis pain.

The patent will be listed in the US Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, or Orange Book. Zorvolex which is approved by the US Food and Drug Administration (FDA) is available at pharmacies across the United States.

“We are excited to receive yet another patent on our flagship product, Zorvolex, which is another testament to our ongoing, successful collaboration with iCeutica,” said Osagie Imasogie, executive chairman of the Board and chief executive officer of Iroko Pharmaceuticals.

The term of the issued patent expires no earlier than 2030. In addition, Zorvolex has three years of regulatory exclusivity from date of product approval through FDA’s regulatory pathway. Iroko and iCeutica continue to prosecute additional patent applications for these and other products in the Iroko portfolio.

GE South Asia & Wipro appoint Milan Rao as president & CEO of healthcare business

GE South Asia and Wipro have appointed Milan Rao to lead GE’s healthcare business as president and CEO, GE Healthcare South Asia and managing director, Wipro GE Healthcare.

Effective May 1, 2015, he replaces Terri Bresenham, who has been leading GE Healthcare’s South Asia business since September 2011. Milan will report to Azim Premji, chairman, Wipro Ltd and Banmali Agrawala, president and CEO, GE South Asia.

Rao will build on Wipro GE’s expansion plans and continue to strengthen the company’s ‘In India, for India’ proposition of innovating disruptive technology and business solutions to enhance access to high quality, affordable healthcare solutions.

Terri, a 25-year veteran at GE, will move to a global role. In the last three years, she has led GE Healthcare to launch winning initiatives like skill building programmes, industry partnerships and breakthrough products such as discovery IQ and revolution ACTs.

“Rao  will take GE’s mission of a Healthier India forward through development of disruptive technologies and business models in India, for India, said Banmali Agrawala, president and CEO, GE South Asia.

“Wipro and GE have enjoyed a strong and enduring partnership lasting over 25 years that has made an indelible mark on India’s healthcare industry. I am confident Rao will further strengthen this relationship and give an added impetus to our mission to build a healthier India,” said Azim Premji, chairman, Wipro Ltd and non-executive chairman, Wipro Enterprises Ltd.

Mylan rejects drug company Teva's $40.1 billion buyout offer

NEW YORK: Mylan N.V. rejected Teva Pharmaceuticals' $40.1 billion buyout offer, saying the cash-and-stock proposal undervalues the company. 

Mylan said that it won't think about starting talks unless Teva offers more than $100 per share, far above its current offer of $82 per share. After the rejection Teva said it is committed to completing the deal and that a sale to Teva is Mylan's best option. 

The rejection comes as both Mylan and Teva look to further consolidate an increasingly competitive generic drug industry. Teva, the world's largest generic drug company, wants to strengthen its position by buying Mylan. Mylan is trying to buy Perrigo Co. of Ireland for about $30 billion in cash and stock, combining its own generic drug business with Perrigo's position in over-the-counter medications and other nonprescription products. Perrigo has rejected Mylan's offer, but the Dutch company says it stands by the bid.

Practo acquires FitHo Wellness

Practo, the doctor search engine, has acquired FitHo Wellness, which is a leading digital fitness solution that has over two million consumers globally.

The acquisition will help Practo rapidly expand its offerings and move into the preventive healthcare space. It will also bring the company to become the single health app for consumers need.

The founders of FitHo, Dhruv and Prachi Gupta will join Practo, with Dhruv taking on the role of product head for preventive and Prachi taking on the role of GM - operations, new segments.

Further, the company also acquires the proprietary algorithm and recommendation engine which automatically suggests custom diets and exercise regimes to users based on their lifestyle, fitness requirements and food preferences.

FitHo’s current offering will phase out over the next 6 months and Practo will launch a completely new preventive product that will leverage some of the technology from FitHo Wellness.

Awareness on vector-borne diseases necessity

World Malaria Day is celebrating on April 25, an effort towards spreading awareness about malaria and its prevention, Dr Rajkumar Chaudhary, Secretary, Association of Hospitals, says, “A continuing theme from last year is Invest in the Future, defeat malaria a part of the WHO initiative, holds the limelight for this year’s World Malaria day. The aim is to completely irradiate the ailment even if the number of cases is reducing year by year, a lack of awareness and preventive measures is still a major cause for concern. Improved awareness initiative programmes, will help to control this fatal disease. The nature of the disease is as such that is difficult to detect, and is not picked up in the first two blood samples. Due to this, there are several cases of patients landing in hospitals with lung, heart, liver problems.

Mumbai is a hotspot of vector-borne diseases owing to its unique environment and demographics. Mumbai is densely packed slums and these areas are always disproportionally impacted. Although the infection rates are high, many people cannot afford anti-malarial drugs, repellent or use mosquito nets. A major chunk of these individuals live below the poverty line and are unable to procure sufficient amenities to protect themselves and their families against Malaria”

The symptoms start around 7-10 days after being bitten by a carrier mosquito. The patient feels fatigued, has bouts of fever every few hours, shivers even when the outside temperature is normal, and suffers from headache, diarrhea, nausea, and vomiting. If immune system is weak, the symptoms may get triggered sooner than usual.

AstraZeneca collaborates with Celgene to develop PD-L1 inhibitor

AstraZeneca and its global biologics research and development arm, MedImmune, announced that they have entered into an exclusive collaboration agreement with Celgene Corporation, a global leader in haematological cancers, for the development and commercialisation of MEDI4736 across a range of blood cancers including non-Hodgkin’s lymphoma, myelodysplastic syndromes and multiple myeloma.

MEDI4736 is an investigational immune checkpoint inhibitor, directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. Within the collaboration, MEDI4736 will be assessed both as monotherapy and in combination with other AstraZeneca and Celgene potential and existing cancer medicines. Over time, the collaboration could expand to include other assets.

MEDI4736 was accelerated into phase III clinical development in non-small cell lung cancer and head and neck cancer. The OCEANS clinical development programme will evaluate MEDI4736 as monotherapy and in combination with a CTLA-4 (tremelimumab) in lung cancer, across the spectrum of the disease. In head and neck cancer, MEDI4736 is being investigated both as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

Merck's anti-PD-1 therapy,

Merck, a global healthcare leader, known as MSD outside the United States and Canada, announced results from the randomized, pivotal phase 3 study, Keynote-006, in the treatment of unresectable advanced melanoma. In the study, Keytruda (pembrolizumab) was statistically superior to ipilimumab for progression-free survival (PFS), overall survival (OS), and overall response rate (ORR).

On March 24, 2015, Merck announced that Keynote-00 would be stopped early based on these data (link). The results were presented at the American Association for Cancer Research (AACR) annual meeting by Dr. Antoni Ribas of Jonsson Comprehensive Cancer Center, University of California, Los Angeles (abstract # CT101), included in the AACR press program, and were also published in the New England Journal of Medicine.

“Improving survival is the ultimate objective in treating patients with cancer. In this important study in advanced melanoma, Keytruda was statistically superior to ipilimumab for progression-free survival and overall survival, and also demonstrated a lower frequency of severe adverse events,” said Dr. Caroline Robert, head of dermatology at Gustave Roussy, Villejuif and Paris-Sud University Cancer Campus, Grand Paris and lead author of the New England Journal of Medicine publication.

In mid-2015, Merck plans to submit a supplemental Biologics License Application (sBLA) for Keytruda based on Keynote-006 for the first-line treatment of advanced melanoma. Merck recently submitted data from Keynote-002 in ipilimumab-refractory advanced melanoma as part of a supplemental application.

Keytruda was the first anti-PD-1 therapy approved in the United States and is currently indicated in the United States for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

AstraZeneca's tremelimumab receives US FDA orphan drug

AstraZeneca announced that the US Food and Drug Administration has granted Orphan Drug Designation for the anti-CTLA-4 monoclonal antibody, tremelimumab, for the treatment of malignant mesothelioma.

Mesothelioma is a rare, aggressive cancer that most often affects the lining of the lungs and abdomen. Available treatments for mesothelioma are very limited, particularly for patients with advanced disease.

“There is a significant need for new treatment options for patients with mesothelioma because fewer than five percent of patients currently survive beyond five years, even when they receive timely diagnosis and care. Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients,” said Robert Iannone, senior vice president, head of immuno-oncology, global medicines development at AstraZeneca.

The Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

US FDA accepts Shire's lifitegrast NDA and granted priority review status

Shire plc announced that the United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, 2015, based on the Prescription Drug User Fee Act V action date.

The FDA grants Priority Review designation to drugs that have the potential to provide significant improvements in the safety or effectiveness for the treatment, diagnosis or prevention of a serious disease. Drugs with Priority Review designation have an accelerated review target of eight months, instead of the standard of 12 months

“Our NDA filing for

The NDA filing is supported by the totality of evidence from four clinical trials with more than 1,800 patients. These include one phase 2 study, two phase 3 efficacy and safety studies, and one long-term phase 3 safety study.
lifitegrast represents an important regulatory milestone, exemplifying Shire’s ability to forge new paths in therapeutic areas aligned with our focus in rare and specialty conditions,” said Philip J. Vickers, Ph.D., head of research and development, Shire. “Our commitment to moving lifitegrast forward reflects our intent to grow in the Ophthalmics therapeutic category in areas of unmet patient need.  We look forward to working closely with the FDA throughout the review process.”

Vanda Pharma receives US patent for Fanapt

Vanda Pharmaceuticals Inc. (Vanda),  a biopharmaceutical company, announced that a Fanapt patent, number 8,999,638 ('638 patent), is now listed in the US Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book.  The '638 patent was issued by the United States Patent and Trademark Office on April 7, 2015 and expires in October 2030.

Prior to this newly listed '638 patent, the Fanapt Orange Book listed patents were the US composition of matter patent and the '610 patent, expected to expire in November 2016 and November 2027, respectively.

Pfizer launches PCSK9 competitive grants programme

Pfizer Inc. announced the launch of a new competitive grants programme the company is funding to support research projects investigating the role of Proprotein Convertase Subtilisin Kexin type 9 (PCSK9) in health and cardiovascular disease. This competitive grants programme, which is an extension of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Cardiovascular programme, is part of Pfizer's ongoing commitment to translate scientific discoveries into innovative medicines for patients with cardiovascular disease.

Pfizer currently is studying bococizumab, an investigational PCSK9 inhibitor, in a phase 3 clinical trial programme, known as SPIRE (Studies of PCSK9 Inhibition and the Reduction of vascular Events), for its potential to lower low density lipoprotein cholesterol (LDL-C) and improve cardiovascular outcomes.

Biocon Foundation wins ‘WHO –India Public Health Champion Award 2015’

Biocon's CSR arm, Biocon Foundation has received ‘WHO-India Public Health Champion Award 2015’ for its initiatives in the area of public health. Biocon Foundation has been recognized for its integrated healthcare initiatives through which it is constantly engaged in improving the quality of life of several thousand communities in India.

The ‘Public Health Champion Award 2015’ is a new  initiative by World Health Organization-India. The awards were presented at a national consultation held to commemorate the World Health Day 2015. Rani Desai, head of Biocon Foundation, received the award from Dr Nata Menabde, WHO representative to India, at a function held in New Delhi.



Expressing her delight at receiving the award, Rani Desai, head, Biocon Foundation said, “ The Foundation has been recognized for its innovative healthcare models of preventive and primary health services through which we are engaged in creating a sustainable health ecosystem. Through our primary health clinics we aim to enable access to affordable healthcare to rural and urban marginalized communities.”

Mylan introduces generic Generess Fe tablets in US markets

Mylan N.V. announced the US launch of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable), which is the generic version of Warner Chilcott's Generess Fe tablets.

Mylan's partner Famy Care Ltd. received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Mylan's immediate shipment of norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable) represents the company's ninth oral contraceptive product launch in the US.

Norethindrone and ethinyl estradiol tablets (chewable) 0.8 mg/0.025 mg and ferrous fumarate tablets, 75 mg (chewable) had US sales of approximately $114.7 million for the 12 months ending December 31, 2014, according to IMS Health.

Baxter, Laboratoire Aguettant sign global pact for parenteral nutrition trace elements

Baxter International Inc.,  a global, diversified healthcare compan, and Laboratoire Aguettant SAS, Lyon, France, have signed an exclusive global licensing and distribution agreement for trace elements, which are essential micronutrients used in parenteral nutrition (PN) therapy. The collaboration allows Baxter to augment its leading PN portfolio, currently available in more than 90 countries, with essential trace elements.

Parenteral nutrition is an intravenous (IV) therapy, which may include a balance of protein, carbohydrates, lipids (fats), electrolytes, vitamins and trace elements for patients who cannot ingest food orally or enterally (tube-fed).

NIH funded study shows HIV can spread early, evolve in patients’ brains

Researchers funded by the National Institutes of Health (NIH) have discovered that the AIDS virus can genetically evolve and independently replicate in patients’ brains early in the illness process.  An analysis of cerebral spinal fluid (CSF), a window into brain chemical activity, revealed that for a subset of patients HIV had started replicating within the brain within the first four months of infection. CSF in 30 percent of HIV-infected patients tracked showed at least transient signs of inflammation – suggesting an active infectious process – or viral replication within the first two years of infection. There was also evidence that the mutating virus can evolve a genome in the central nervous system that is distinct from that in the periphery.



“These results underscore the importance of early diagnosis and treatment with antiretroviral therapy,” said Dianne Rausch, Ph.D., director of the Division of AIDS Research of the NIH’s National Institute of Mental Health (NIMH). “Any delay runs the risk that the virus could find refuge and cause damage in the brain, where some medications are less effective – potentially enabling it to re-emerge, even after it is suppressed in the periphery.”

Fujifilm to buy Cellular Dynamics International for $307 million

Fujifilm Holdings Corporation (Fujifilm) and Cellular Dynamics International, Inc. (CDI), a leading developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, have entered into a definitive agreement whereby Fujifilm will acquire CDI via an all-cash tender offer to be followed by a second step merger.










Fujifilm aims to acquire all issued and outstanding shares of CDI's common stock for $ 16.5 per share or approximately $307 million (on a fully diluted basis). The offer represents a premium of 108% to CDI's closing price on March 27. Upon completion of the transaction, CDI will continue to run its operations in Madison, Wisconsin and Novato, California as a consolidated subsidiary of Fujifilm. The announced transaction was unanimously approved by the Boards of Directors of both companies.

Under the terms of the agreement, Fujifilm will commence an all-cash tender offer no later than April 6, 2015. The transaction is conditioned on the tender achieving the minimum acceptance threshold, regulatory approvals and other customary conditions. Fujifilm will finance the transaction from the cash on its balance sheet and the completion of the acquisition is not subject to any financing conditions. It is anticipated that the tender offer will close during the second calendar quarter of 2015.

CDI was founded in 2004 and listed on NASDAQ in July 2013. The company had global revenues of $16.7 million in the year ended, December 31, 2014 and had 155 employees as of December 31, 2014.

Nanolek to commercialise Green Cross' biologics in Russian market

South Korean biopharmaceutical company, Green Cross and Nanolek, a Russian pharmaceutical company, have entered into a strategic partnership agreement for the commercialisation of Green Cross' biologics in the Russian market.

Under the terms of the agreement, Nanolek will obtain marketing authorisations and set up the production of a number of Green Cross' biologics. The production will be organised at Nanolek's facility, a state-of-art biopharmaceutical complex built and equipped in compliance with EU GMP standards and launched in December 2014.

"This partnership is a perfect strategic fit for Green Cross' global business model," said EC Huh,  president of Green Cross Corporation. "We are excited to work with the team at Nanolek, and to share in the longer-term commercial success of Green Cross' products as it enters Russia."

"Our project with Green Cross will make socially significant drugs more accessible and minimize the state's financial burden for the procurement of these drugs outside of Russia," said Mikhail Nekrasov, CEO of Nanolek. "Making possible the domestic production of a number of biopharmaceuticals is our contribution to the implementation of the government policy in developing the Russian pharmaceutical industry."

Russia's pharmaceutical market is one of the most attractive in the emerging European region, mainly due to its absolute size, plus a growing economy and increasing government investment in healthcare, according to a report from Business Monitor International. The Russian market is set to grow at twice the pace of the global pharmaceutical market, with growth estimates around 10-15% annually reaching an approximate market value of $43-60 billion by 2020.

Cadila buys 50% stake of Zydus BSV from Bharat Serums

Cadila Healthcare Ltd, a Rs.7,200 crore pharma major from Ahmedabad, has purchased 50 per cent shares of Zydus BSV Pharma Pvt Ltd (Zydus BSV) from Bharat Serums and Vaccines Ltd (BSV) and now Zydus BSV has become 100 per cent subsidiary of Cadila Healthcare.







BSV is engaged in research, manufacturing and marketing injectable biological, pharma and biotech products. Its product portfolio comprises 25 brands which include plasma derivatives, monoclonals, fertility hormones, antifungals, anaesthetics, cardiovascular drugs and equine immunoglobulins/antitoxins.

B Jain Pharma launches Omeo Calendula, an antiseptic spray

B Jain Pharmaceuticals, one of the leading manufacturers and marketers of homoeopathic medicines, has introduced its latest product, Omeo Calendula, an antiseptic spray to treat wound. The product is available at all leading homeopathic shops in India.







Omeo Calendula Spray is an antiseptic medicine that heals abrasion, wounds, carbuncles and surgical cuts quickly. It prevents suppuration and favors phagocytosis. the homeopathic antiseptic is rolled out in 30ml sprayers.

Nishant Jain, director of B Jain Pharmaceuticals says, “Our products are gaining good response in the market. Omeo Calendula will soon be a leading antiseptic in the medical industry. I believe our consistent quality in manufacturing has been the sole reason of our survival. We are observing a new optimistic surge in the market for homoeopathy.”

Biotech startup to fight diabetes on the cellular front

New Cambridge biotech will be working on a treatment using stem cells that could let children and adults with Type 1 diabetes do something their bodies currently cannot: produce their own insulin, the hormone that keeps blood sugar levels in balance.

Semma Therapeutics is already off to a strong start. On Tuesday, the company will disclose it has raised $44 million from big-name investors, including Boston’s MPM Capital, to commercialize research from the lab of noted Harvard stem cell scientist Douglas Melton.






The startup, which is in the process of hiring employees and leasing lab space, is seeking to offer a different treatment approach in a field that hasn’t seen significant change for decades.
“This would be a huge breakthrough,” said Dr. George L. King, a Harvard Medical School professor and research director at Joslin Diabetes Center. “It could cure diabetes.”
But it is still likely to be years before Semma’s approach — transplanting insulin-secreting pancreatic “beta cells” into patients — will be available commercially.

First, Semma Therapeutics will have to surmount a daunting scientific challenge: overcoming the autoimmune response in Type 1 diabetes patients that causes their bodies to reject and destroy their own pancreatic cells, which naturally make insulin.
Felicia Pagliuca, who was a postdoctoral fellow in Melton’s lab in the Harvard Stem Cell Institute from 2011 to 2014, led a team that came up with a way to turn stem cells into cells that can produce insulin. Now, as Semma’s scientific cofounder, she will be working to turn those cells into a business — and a treatment for Type 1 diabetes.

Biogen Idec renames as Biogen

Biogen Idec, a company discovers, develops and delivers to patients worldwide innovative therapies, announced that the company has changed its name from Biogen Idec to Biogen with effect from March 23, 2015.

The company has introduced a new corporate identity and logo that reflect both its evolution and focus on bringing forth new therapies in areas of high unmet need – while honoring Biogen’s scientific heritage and legacy as a pioneer in the biotechnology industry.

Biogen Idec was created in 2003 through the merger of Biogen and IDEC Pharmaceuticals, creating one of the world’s leading research-based life sciences organizations. The company has since focused its research and commercial efforts in three core areas: neurology, immunology and hematology.

Biogen’s common stock will continue to trade on the Nasdaq Global Select Market under the symbol “BIIB,” and its CUSIP number will not change.

Pfenex gets early HSR clearance for collaboration with Hospira

Pfenex Inc., a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics including high value and difficult to manufacture proteins, announced that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with the exclusive collaboration agreement executed by the company on February 9, 2014 with Hospira, Inc. to develop and commercialize, PF582, Pfenex's biosimilar product candidate to Genentech's Lucentis (ranibizumab injection).

With the early termination of the applicable waiting period under the HSR Act, the collaboration agreement with Hospira is effective as of March 19, 2015 and the $51 million initial payment under the collaboration agreement is due to the company on or before the fifth business day following HSR clearance.

Pfizer presents positive results from pivotal phase 3 psoriasis trials of oral tofacitinib

Pfizer Inc. has presented the detailed pooled results from two pivotal phase 3 studies from the oral treatment Psoriasis Trials (OPT) programme at the 73rd American Academy of Dermatology (AAD) Annual Meeting. These results, evaluating the efficacy and safety of tofacitinib citrate for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, have been selected for oral presentation during the Pearls from the Posters New and Noteworthy Research Finds [abstract 2020].

Additionally, an integrated analysis of safety data from the OPT global clinical development program for tofacitinib was presented during the Late-Breaking Research in Dermatology Forums

”We are excited about the data presented at AAD as it adds to the body of evidence for oral tofacitinib in patients with moderate to severe plaque psoriasis. Results from these studies, which are part of the phase 3 OPT clinical development program, supported Pfizer’s recent FDA filing seeking a psoriasis indication in the United States,” said Steve Romano, MD, senior vice president and Head, Global Medicines Development for the Pfizer Global Innovative Pharmaceutical business.

The detailed, pooled analysis of 16 week data from the OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib 10 mg and 5 mg tablets twice daily met the co-primary efficacy endpoints of superiority over placebo at 16 weeks in the proportion of patients achieving a Physician’s Global Assessment (PGA) response of “clear” or “almost clear,” and the proportion of patients achieving at least a 75% reduction in Psoriasis Area and Severity Index (PASI75), two commonly used measures of efficacy in psoriasis. Both the tofacitinib 10 mg and 5 mg twice-daily doses showed statistically significant superiority over placebo for key secondary efficacy endpoints presented at AAD, including proportion of patients achieving =90% reduction in PASI (PASI90) relative to baseline at Week 16, percent change from baseline in Body Surface Area (BSA) at Week 16, change from baseline in Dermatology Life Quality Index (DLQI) at Week 16, and percent change from baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 in patients with nail psoriasis.

BIRAC launches 'BIRAC AcE Fund' - biotechnology

The Biotechnology Industry Research Assistance Council (BIRAC) has launched an equity fund “BIRAC AcE Fund” to address to accelerate the growth of entrepreneurs, in the field of biotechnology.

The equity fund is aimed at addressing the pressing needs of accelerating the growth of entrepreneurs, in the field of biotechnology. This fund will be operated by BIRAC, a public sector undertaking under the department of biotechnology, ministry of science & technology, Government of India with incubators and business accelerators, as its partners.

The minister of state for science & technology and earth sciences Y S Chowdary announced the launch of–“BIRAC AcE Fund” on March 19.

Speaking on the occasion of the third foundation day of BIRAC in New Delhi yesterday, the minister expressed hope that this major step taken by the government would dramatically change the landscape of the biotech start-up ecosystem in the country. He said that this is important and a major decision wherein the government will be a partner in equity funding for start-ups. The minster also mentioning several budgetary provisions that are aimed at encouraging self employment and start ups said that a help-desk is proposed to be set up in his ministry for people wanting to know of these schemes.

Sigma-Aldrich signs agreement to distribute Roche's biochemical reagents product portfolio

Sigma-Aldrich Corporation, a leading life science and technology company, has signed an exclusive global distribution agreement with Roche. The agreement pairs Roche's high-quality biochemical reagents product portfolio with the industry-leading eCommerce and supply chain capabilities of Sigma-Aldrich.

Under the agreement, Sigma-Aldrich will employ its sales, marketing and eCommerce expertise, and leverage the strength of its relationships with the scientific community, to present and distribute the Roche biochemical reagents product portfolio, which includes kits and enzymes for cellular analysis, proteomics and conventional PCR applications.

"Sigma-Aldrich is excited to offer the global scientific community access to Roche's leading portfolio of scientific tools and reagents. The addition of these life science tools supports our strategy to augment our portfolio with products that accelerate customer scientific research programs," said Eric Green, executive vice president and president, Sigma-Aldrich Research. "We look forward to working with Roche in this relationship."

"This agreement allows us to provide more customers with access to high-quality Roche biochemical reagent products through Sigma-Aldrich's expanded eCommerce and distribution networks," said Paul Brown, head of Roche Molecular Diagnostics. "In addition, this will provide us the flexibility to devote more resources to our primary focus areas."

Transition of the Roche portfolio to Sigma-Aldrich is expected to take place in 2015. In the interim, these products will continue to be available through existing Roche channels.

Government to soon come up with 10 pharma clusters in the country

While releasing the report of proceedings at the 12th National Pharmaceuticals Conclave recently, Union chemicals and fertilizers minister Ananth Kumar announced setting up of 10 pharma clusters in the country with an outlay of Rs. 120 crore in the next one year. He explained that these clusters will provide common facilities to the pharmaceutical industry, and help them hive off up to 25% of the cost, making them globally competitive. A strategy to develop the clusters has been framed for its early implementation, he informed.

The Minister further said that that there are valuable suggestions in the report which will be promptly examined, and taken up for action. He said that the Government wants to ensure that four pillars of the industry - Quality, Affordability, Availability and Stability are in position. He said that the Government wants to provide health security for the poor people of the country, and this requires innovative strategies, like supply of generic medicines, building domestic capacity in bulk drugs, and making pharma sector competitive.

A unified policy, regulation and administration mechanism is required for the pharmaceutical industry, and the Minister has therefore recommended to the Prime Minister to set up a separate department for the same. He said that on the issue of bulk drugs production in the country, Katoch Committee Report has been received in the Ministry, and an action plan is being prepared for its implementation. Once its recommendations are put in place, it will make Indian industry viable and competitive.

Speaking on the occasion, the Minister of state for chemicals and fertilizers, Hansraj Gangaram Ahir said that close interaction with producers and consumers helps the Government in formulating a better policy. He said that industry and national growth go hand in hand.

AstraZeneca, Daiichi Sankyo to jointly commercialise Movantik in US

AstraZeneca announced a co-commercialisation agreement with Daiichi Sankyo, Inc. for Movantik (naloxegol) in the US, in line with the Company’s strategy of delivering value through its own development and commercial capabilities as well as through external collaboration. Movantik is a first-in-class once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

Movantik was approved by the US Food and Drug Administration in September 2014. It was descheduled by the US Drug Enforcement Administration in January 2015 and is no longer labelled as a controlled substance. The launch of Movantik in the US is planned for early April 2015.

Under the terms of the agreement, Daiichi Sankyo Inc. will pay a $200 million up-front fee and subsequent sales-related payments of up to $625 million. AstraZeneca will be responsible for manufacturing, will book all sales and will make sales-related commission payments to Daiichi Sankyo, Inc. Both companies will be jointly responsible for commercial activities. AstraZeneca’s 2015 financial guidance, provided on 6 March 2015, is unaffected by today’s announcement.

Paul Hudson, president, AstraZeneca US and executive vice president, North America, said: “We are delighted to collaborate with Daiichi Sankyo to expand our commercialisation efforts in the US in order to get this important medicine to the large number of patients suffering with opioid-induced constipation. Our agreement reflects our evolving business model by creating value from our portfolio through externalisation activity. Together, we will grow the potential of this important treatment, while we retain our significant interest in the long-term commercial success of Movantik in our largest market.”

Lupin buys balance 40% stake in South African-based Pharma Dynamics

Lupin, the fourth largest pharma major with net sales of Rs. 11,200 crore plus, has entered into an agreement to acquire the balance 40 per cent equity stak e in South African generics major, Pharma Dynamics (PD)  from its founders.

As per the agreement, the found ers will exercise their put option before March 31, 2015, for  the 40 per cent equity stake it currently holds. On comple tion of this transaction, PD will become a wholly owned  subsidiary of Lupin, subject to closing conditions.

Headquartered in Cape Town, South Africa (SA) Pharm a Dynamics was founded in the year 2001 and distributes a range of branded, generic prescription medicines and over-the-counter (OTC) products in SA as well as other key markets across the African continent.

It was in September, 2008 that Pharma Dynamics (PD) and Lupin Limited set out on a shared mission to provide effective and affordable healthcare products to patients in South Africa and the African continent. Lupin acquired a strategic 60 per cent equity stake in PD. Today, PD is amongst the fastest growing top 20 pharmaceutical companies in SA and the 3rd largest generic company in the SA prescriptions market. It is the biggest supplier of cardiovascular pharmaceuticals in SA by both value and volumes. Its products also address therapies such as central nervous system (CNS), gastrointestinal, diabetes and gynecological and male health segments. In 2013, it also entered the SA anti-infective market, supplying IV antibiotics to hospitals. Its OTC products portfolio includes antihistamines, cold & flu medication and heartburn treatment.

Talking about the development, Paul Anley, CEO of Pharma Dynamics said, “Lupin has been an extremely strong partner in our business since 2008 and we have always had an excellent relationship” he further added, and “The fact that Lupin has increased its shareholding in Pharma Dynamics is a huge compliment and augers very well for our continued success.”

The acquisition represents significant foreign investment into SA and is a major vote of confidence in the business. It will add additional global muscle to Pharma Dynamics’ operations and support the next phase of growth for the company.

GlaxoSmithKline invests $25 mn to become partner in new global fund for dementia research

GlaxoSmithKline (GSK) announced it will be a key partner, with an investment of $25 million (approx £17 million), in a pioneering new global fund for dementia research. The Dementia Discovery Fund, which is being established by the UK government with initial commitments totalling $100 million, brings together leading pharmaceutical companies, the UK government and Alzheimer’s Research UK to address the rising threat posed by dementia by supporting research into future treatments.

The fund aims to identify and nurture promising new avenues of research from around the world in the field of dementia and supports GSK’s commitment to explore novel, collaborative approaches in challenging areas of research. It is hoped that by providing critical financial support and expert advice during the early stages of research, the development of innovative new treatments for this disease could be accelerated.

Dementia poses a serious and rising threat to public health and healthcare systems globally. According to the World Health Organization more than 35 million people are living with dementia worldwide. This number is expected to triple by 2050, yet there are currently no medicines available to prevent or cure this disease. This is due to the complexity of the brain, which makes finding new treatments for neurodegenerative conditions like dementia exceptionally difficult scientifically.  Coupled with this, the slow onset of disease and diverse range of symptoms associated with it means that clinical trials for potential new treatments are very challenging to carry out. The failure rate in the development of new medicines for dementia and other neurodegenerative diseases currently stands at 95% for assets in clinical development, which is about double the failure rate seen in other areas of research.

Patrick Vallance, president of pharmaceutical R&D at GSK, said: “The rise of dementia is fast becoming one of the world’s greatest health threats, and in order to reverse the tide on this, it’s imperative that the scientific community works together, sharing knowledge and expertise with one another. Today’s announcement signals a unique opportunity for us to translate some of the world’s most promising research in this field in to life changing medicines. This Fund is a really smart way of bringing together great minds and communally increasing our understanding of dementia. It’s also a good way of sharing the financial risk associated with conducting drug discovery research in this field.

Moderate coffee consumption lessens risk of clogged arteries, heart attacks

People who drink a moderate amount of coffee daily are less likely to develop clogged arteries that could lead to heart attacks, reveals research published online in the journal Heart. Researchers from South Korea found that people consuming three to five cups a day had the least risk of coronary calcium in their arteries.

There has been much debate over the effect of coffee consumption on cardiovascular health. Despite earlier concerns about a potential increase in heart disease risk associated with drinking coffee, a recent meta-analysis of 36 studies showed that moderate coffee consumption was associated with a decreased risk of heart disease. Coffee consumption has been associated with improved insulin sensitivity and reduced risk of type 2 diabetes, but it has also been linked to increased cholesterol concentrations and heightened blood pressure.

An international team of researchers led by the Kangbuk Samsung Hospital, Seoul, in the Republic of Korea, set out to examine the association between coffee consumption and the presence of coronary artery calcium (CAC) which is a early indicator of coronary atherosclerosis – a potentially serious condition where arteries become clogged up by fatty substances known as plaques or atheroma and which can cause the arteries to harden and narrow, leading to blood clots which can trigger a heart attack or a stroke.

They studied a group of 25,138 men and women – average age of 41 – who had no signs of heart disease, attending a health screening examination.

The participants’ screening examination included a validated food frequency questionnaire and a multidetector cardiac CT (computed tomography) for diagnostic imaging to determine levels of coronary artery calcium (CAC) scores.

Annual or biennial health screening examinations are common in Korea, because health examinations are mandatory for all workers under the Industrial Safety and Health Law there and CAC scoring has become a common heart disease screening test.

Cipher buys 3 inflammatory dermatological products from Astion

Cipher Pharmaceuticals Inc., a specialty pharmaceutical company,   has strengthened its product pipeline by acquiring the worldwide rights to three products from Astion Pharma (Astion), a Denmark-based specialty pharmaceutical company. The three products are focused on inflammatory dermatological diseases: Dermadexin, Pruridexin, and ASF-1096.

Dermadexin is a patent-protected topical barrier-repair cream containing the pharmacologically active ingredient P3GCM. The product was approved in the European Union (EU) in 2014 as a Class III medical device for the treatment of seborrheic dermatitis, an inflammatory skin disorder affecting the scalp, face, and torso. Dermadexin SD Cream has been tested in two placebo-controlled, multicenter clinical trials (436 patients) where it displayed a marked and statistically significant effect on the symptoms of facial seborrhoeic dermatitis with a fast onset of action and an increasing effect over time.

Pruridexin is a patent-protected topical cream for the treatment of chronic pruritis (itching), which is a significant unmet need. Pruridexin was submitted to the European Medicines Agency in 2014 as a Class III medical device and is under active review with a response expected in the first half of 2015. Pruridexin Cream has been tested in two placebo-controlled, multicenter clinical trials (352 patients) and displayed a marked and statistically significant effect on the pruritus with a fast onset of action and an increasing effect over time.

new point-of-care system for HIV/AIDS CD4 monitoring in India

Becton, Dickinson and Company has now unveiled the  BD FACSPresto, a near patient CD4 monitoring system that provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples.

The device weighs  less than 7kgs and  is capable of testing samples from a single drop of capillary or venous blood and can work for 6 hours using in-built rechargeable battery, enabling testing even in remote settings.

National AIDA Research Institute (NARI), Pune conducted a product evaluation study on the new near patient CD4 Counter system on close to 150 samples and have claimed the accuracy of the tests after conducting a systematic study.  The Institute researchers found that the accuracy and precision levels of BD FACSPresto was equivalent to the current gold standard.

CD4 testing allows HIV/AIDS patients to have access to treatment and monitoring, reducing the probability of transmitting the infection to others and providing a plan for improved long-term care. Immediate treatment for infected individuals who meet medical guidelines can dramatically quell the spread of HIV, according to the World Health Organization (WHO). This is particularly important as many new cases of HIV/AIDS are transmitted from people who are not aware they are infected.

Sigma introduces Next-Gen Sequencing Oligos

Sigma Life Science, an innovative biological products and services business of Sigma-Aldrich Corporation, released Next-Gen Sequencing Oligos, custom next-generation sequencing adapters that improve target sequence assembly. These oligos are expected to allow researchers to achieve better results from multiplexing experiments. "Sigma-Aldrich is the first oligonucleotide manufacturer to provide a cross-contamination threshold," said Carlos Martinez, development manager at Sigma-Aldrich. "This gives our customers the confidence they need from the start, minimizing the time and expense created by the need to experiment with less consistent products to achieve proper sequence assembly." Next-generation sequencing adapters are required for the proper assembly of genome sample fragments. Adapters, especially barcode sequences, containing unacceptably low full-length sequence or excessive cross-contamination with other barcode sequences can lead to compromised sequence read integrity and improper sequence assembly. These types of problems are often undetectable until the data analysis stage, which make them costly in terms of time and money. Sigma's Next-Gen Sequencing Oligos are manufactured under rigorous conditions to ensure suitable purity and low levels of cross-contamination. "With cross-contamination thresholds as low as 0.25% or less, and both ISO 9001 and 13485 manufacturing available, Next-Gen Sequencing Oligos are ideal for research, life science research tool and molecular diagnostic applications," said Martinez. Sigma Life Science is a Sigma-Aldrich business that represents the company's leadership in innovative biological products and services for the global life science market and offers an array of biologically-rich products and reagents that researchers use in scientific investigation. Sigma-Aldrich, a leading life science and technology company focused on enhancing human health and safety, manufactures and distributes 230,000 chemicals, biochemicals and other essential products to more than 1.4 million customers globally in research and applied labs as well as in industrial and commercial markets.

Sanofi inks research pact with Lead Pharma to develop treatments for autoimmune diseases

Sanofi has entered into a research collaboration and license agreement with Lead Pharma,  a Dutch biotech company, to discover, develop and commercialize small-molecule therapies directed against the nuclear hormone receptors called ROR gamma (t) to treat a broad range of autoimmune disorders, including rheumatoid arthritis, psoriasis and inflammatory bowel disease, which are among the most common.

"Anti-ROR gamma (t) therapies represent a ground-breaking opportunity that we are eager and motivated to pursue through our collaboration with Lead Pharma," said Christian Antoni vice president and head of the immunology & inflammation franchise, research & development, Sanofi. "At Sanofi, we believe networked innovations - working collaboratively across science sectors - is the most effective way to bring meaningful new therapies to patients. To this end, Lead Pharma's innovative capabilities and productivity, exemplified by the ROR gamma (t) programme, make them ideal partners for Sanofi in this area of drug discovery."

Boston Scientific to pay $600 mn to J&J to resolve Guidant litigation

Boston Scientific Corporation announced the settlement of the breach of merger agreement lawsuit brought by Johnson & Johnson against Guidant Corporation, stemming from Boston Scientific's acquisition of Guidant. In the lawsuit filed in 2006, Johnson & Johnson alleged that Guidant breached the merger agreement it had with Johnson & Johnson, and sought more than $7 billion in damages. Guidant disputed the allegations. As a result of the settlement agreement, Johnson & Johnson has agreed to permanently dismiss its action without acknowledgment of liability by Guidant.

Additionally, Boston Scientific will make aggregate payments totaling $600 million to Johnson & Johnson.  Boston Scientific expects to record a pre-tax litigation-related charge of approximately $600 million within its fourth quarter 2014 results as a recognised subsequent event. This charge will be excluded from Boston Scientific's non-GAAP measures of adjusted income that were previously announced. In connection with the settlement, Boston Scientific has also agreed not to bring patent infringement or other claims related to Johnson & Johnson's S.M.A.R.T., S.M.A.R.T. Control, and S.M.A.R.T. Flex stent products.

"We feel this settlement is in the best interests of the company and its shareholders," said Tim Pratt, executive vice president, chief administrative officer, general counsel and secretary. "We are pleased to end this longstanding litigation between Guidant and Johnson & Johnson, and to continue focussing on delivering innovative products and solutions to physicians and patients."

 

Teva Pharma launches generic Lovenox & Zyvox in US markets

Teva Pharmaceutical Industries, a leading global pharmaceutical company, announced the launch of the generic equivalent of Lovenox (enoxaparin sodium injection) in seven dosage strengths in the United States. Enoxaparin s injection, USP is used for prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal surgery, hip or knee replacement surgery, or in medical patients with severely restricted mobility during acute illness; and also for the treatment of acute DVT.

Lovenox had annual sales of approximately $1.8 billion in the United States, according to IMS data as of November 2014. Under a licensing agreement, Teva has partnered with Chemi SPA to leverage their internal research based technology in the development and manufacture of enoxaparin sodium injection, USP.

Teva has also recently launched the generic equivalent to Zyvox (linezolid) injection which is used for the treatment of infections caused by Gram-positive bacteria. Zyvox injection had annual sales of approximately $464 million in the United States, according to IMS data as of October 2014.

“Teva is committed and focused on building a stronger generic injectable business globally,” said Siggi Olafsson, president and chief executive officer, of Teva Global Generic Medicines. “With the launch of enoxaparin sodium injection, USP and Linezolid injection, accompanied by the reintroduction of three generic injectable products, we are leveraging the strength of our internal and external resources to deliver the right portfolio as part of our growth strategy. As the number one generics company in the world, we can quickly bring a range of high-quality, cost-effective generic injectable treatments to patients within the doctor’s office, hospital, or clinic.”

Teva continues to invigorate the injectable business in the United States with a selective reintroduction of older generic injectable products as well as continued investment in newer, higher-value generic injectable products. Additionally, Teva has progressed in building its research and development capabilities in complex, generic injectables including drug-device combinations, complex drug delivery, and complex molecules. This month, Teva has launched Nafcillin for injection, USP and is reintroducing into the market Leucovorin calcium for injection (100 mg/vial), methylprednisolone acetate injectable suspension, USP (40 mg/mL), and ondansetron injection, USP (2 mg/mL).

As of January 22, 2015, Teva had 120 product registrations pending FDA approval, including 29 tentative approvals. Collectively, these 120 products had US sales in 2014 exceeding $86 billion. Of these applications, 87 were “Paragraph IV” applications challenging patents of branded products; 42 of these pending ANDAs are potential first-to-file opportunities.