Compliance with global standards to make India a pharma manufacturing hub

The Indian pharmaceutical industry is poised to reach $ 55 billion by 2020, of which $ 30 billion will be accounted for exports. The crucial factors to achieve the true potential of industry are affordability, strong infrastructure, and the ease of doing business. "We need to think how to create ease of doing business without compromising quality and affordability," opined Pankaj Patel, chairman and managing director, Zydus Cadila, and senior vice president, FICCI, chair - FICCI Pharmaceutical Committee, during a seminar on Indian pharmaceuticals industry at the Make In India Week event in Mumbai yesterday.

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Lauding the industry for being a world leader in generic and pharmaceuticals, and a reliable supplier of affordable medicines, Patel said, "India has the largest number of US FDA-compliant plants. The Make In India initiative is a timely response devised to transform India into a global designing and manufacturing hub. This calls for a complete change in mindset."

US FDA accepts Mylan's ANDA filing for generic Advair Disku

Mylan N.V., a global pharmaceutical company committed to setting new standards in healthcare, announced that its abbreviated new drug application (ANDA) for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder has been accepted for filing by the US Food and Drug Administration (FDA).



The FDA provided Mylan a GDUFA goal date of March 28, 2017. This product is the generic version of GlaxoSmithKline's Advair Diskus, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Mylan CEO Heather Bresch said, "The FDA's acceptance of our ANDA filing is an important achievement for our generic Advair Diskus development program and our respiratory franchise as a whole. Leading up to this milestone, we held several discussions with FDA to provide input on and solidify our understanding of the agency's expectations for the development of the first AB-rated generic Advair Diskus product. Our ongoing dialogue with FDA and this ANDA filing acceptance gives us further confidence in the robustness of our clinical programme and reinforces our continued belief that Mylan will be the first to bring to market an AB-rated, substitutable generic form of Advair Diskus."

Specialty chemicals industry: Making India a global manufacturing powerhouse

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Unlike many of the other emerging countries, where manufacturing has been the main growth engine (growing much faster than GDP), India banked on services sector to fuel its economic development. As a result, in spite of registering a healthy average GDP rate of 8-9 percent during 2005-2012, the manufacturing sector's contribution to the GDP remained stagnant at 16 percent. Realising the importance of manufacturing to provide sustainable livelihood to growing population, the new government is taking steps to revitalise the sector by setting the juggernaut rolling with the Make in India initiative.
 
To make India a global manufacturing hub, the government will have to create conducive environment for a thriving eco-system wherein suppliers to product manufacturers can also flourish. One of the key components of this ecosystem is chemicals, which go into every product that one can imagine. In fact, development of any economy or country is directly linked to the per capita consumption of chemicals.

Biocon gets EU approval for generic version of Rosuvastatin Calcium

Biocon has received European approvals for its Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets. The company has stated its Rosuvastatin Calcium is a generic equivalent of Crestor of AstraZeneca tablets, indicated for hyperlipidemia or mixed dyslipidemia.

This first generic formulations approval in the regulated markets marks an important milestone in Biocon's small molecules strategy of forward integration from APIs to finished dosages. The approval for Rosuvastatin Calcium, through decentralized procedure will open the doors for Biocon to over 15 European countries and will enable the company to address US$ 1.2 billion opportunity, starting FY17. It is the first generic company to receive a Certificate of Suitability (CEP) for Rosuvastatin Calcium API from the European Directorate for the Quality of Medicines (EDQM). CEP certification indicates that an API is suitable for use in medicinal products in the EU, according to the company.

"This is indeed a proud moment for Biocon's small molecules business. This approval paves the way for us to launch Rosuvastatin Calcium tablets in several European countries. We plan to collaborate with regional partners in the near term to provide access to this affordable generic and thus help patients and governments to bring down their healthcare spends," said Kiran Mazumdar-Shaw, CMD, Biocon.

According to Dr. Arun Chandavarkar, CEO and joint managing director, Biocon, the European approval for our generic version of Rosuvastatin Calcium underscores our strength in the chronic therapies space and our compliance with global standards that enable us to achieve the highest quality standards for all our products. It augurs well for this nascent business, which will be one of our growth drivers in the coming years.

Cidara's antifungal drug, CD101 IV receives US FDA orphan drug status

Cidara Therapeutics, Inc., a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its antifungal drug candidate, CD101 IV, for the treatment of candidemia and invasive candidiasis.

Orphan drug designation of CD101 provides Cidara eligibility for seven years of market exclusivity in the United States upon FDA approval, a waiver from payment of User Fees, an exemption from performing clinical studies in pediatric patients, and tax credits for the cost of the clinical research. The seven-year period of marketing exclusivity provided through orphan designation combined with an additional five years of marketing exclusivity provided from the previously announced QIDP designation positions CD101 IV for a total of 12 years of potential marketing exclusivity to be granted at the time of FDA approval.

"This designation underscores the need for new drugs to treat severe fungal infections and is another in a series of milestones that demonstrate the promise of our novel, long-acting echinocandin, CD101 IV," said Jeff Stein, Ph.D., president and CEO of Cidara. "Our phase 1 data demonstrating the safety and tolerability of up to three doses of high exposure, once-weekly CD101 IV enables us to initiate our phase 2 study in candidemia early this year. We believe CD101 IV has the potential to become a best-in-class echinocandin antifungal."

Mylan to buy Meda for US$ 9.9 billion

Mylan N.V., a leading global pharmaceutical company (Mylan), announced a recommended public offer to the shareholders of Meda Aktiebolag (publ.) (Meda) to tender all their shares in Meda to Mylan (the Offer). The total offer consideration consists of a combination of cash and Mylan ordinary shares (Mylan Shares) with a value at announcement of SEK 165 per Meda share. The total value of the offer for all Meda shares, including Meda net debt, is approximately SEK 83.6 billion or USD 9.9 billion, which represents a multiple of approximately 8.9x 2015 adjusted EBITDA with synergies.

The combination of Mylan and Meda will create a diversified global pharmaceutical leader with an expansive portfolio of branded and generic medicines and a strong and growing portfolio of over-the-counter (OTC) products. The combined company will have a balanced global footprint with significant scale in key geographic markets, particularly the US and Europe. The acquisition of Meda also provides Mylan with entry into a number of new and attractive emerging markets, including China, Southeast Asia, Russia, the Middle East and Mexico, complemented by Mylan's presence in India, Brazil and Africa. Mylan and Meda have a highly complementary therapeutic presence, which will create a leading global player in respiratory/allergy, and achieve critical mass in dermatology and pain, offering greater opportunities for growth in these categories.

The offer has been unanimously approved by Mylan's board of directors and unanimously recommended by Meda's board of directors. Meda's two largest shareholders, representing in the aggregate approximately 30 per cent of Meda's outstanding shares, have undertaken to accept the offer, subject to certain conditions. Meda's shares are listed on Nasdaq Stockholm, Large Cap. The offer is subject to the satisfaction of a number of customary conditions, including clearance from relevant competition authorities, and is expected to be completed by the end of the third quarter of 2016. The offer is not subject to approval by Mylan shareholders and is not subject to any financing conditions

EMA accepts Sandoz's MAA for biosimilar pegfilgrastim

Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency (EMA) has accepted their Marketing Authorisation Application (MAA) for its biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim) - a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product.

Commenting on today's milestone, Richard Francis, Division Head and CEO Sandoz said, "Securing five major regulatory file acceptances in five months demonstrates substantial progress on our long-term biosimilars investment strategy. Further advancing our biosimilars pipeline is an important priority for us this year and we'll continue to invest significantly in bringing our pipeline to patients."

Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with some of the side effects of their treatment. It reduces the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment. The incidence of febrile neutropenia (FN) occurring with common chemotherapy regimens is 25 to 40 per cent of treatment-naive patients

Supernus Pharma gets favourable US ruling in Oxtellar XR ANDA litigation

Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and commercializing products for the treatment of CNS diseases, announced that following a seven-day bench trial, Judge Renee Marie Bumb of the United States District Court for the District of New Jersey ruled that Actavis Inc. and its subsidiaries infringed US Patent Nos. 7,722,898 and 7,910,131 by submitting to the FDA an ANDA seeking permission to market a generic version of Oxtellar XR before the expiration of Supernus' patents.  Judge Bumb also ruled that US Patent Nos. 7,722,898, 7,910,131, and 8,617,600 are valid.  The FDA's Orange Book lists all three patents as expiring on April 13, 2027.

"We are pleased with the court's ruling that Actavis will infringe two of our patents on Oxtellar XR, and the finding that all three patents are valid," stated Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals. "We will continue to vigorously defend our novel products and build upon our strong intellectual property to provide our products the protection they are entitled to."

SAKIGAKE Designation System

Daiichi Sankyo Company, Limited (Daiichi Sankyo) announced that the oncolytic virus therapy for cancer (G47?) jointly developed with Dr. Tomoki Todo, a professor at the University of Tokyo’s Institute of Medical Science, has been designated under the SAKIGAKE Designation System for medical equipment and in vitro diagnostic pharmaceuticals and regenerative medicine products, which was launched this year.

Professor Todo initiated the GCP based second-phase G47? clinical trial targeting glioblastoma in 2015. G47? has performed well in the study, and non-clinical researches and clinical researches for other carcinomas have already begun. Based on data obtained thus far, it has also been suggested that there is a possibility of expanding indications to other types of cancer. In the future, Daiichi Sankyo intends to collaborate with Professor Todo on the further development of this cancer treatment method.

Daiichi Sankyo remains committed to meeting the needs of more patients and medical professionals through drug development and contributing to medical care by providing new treatment options.