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.