As the market for new drugs evolves, the methodologies for moving them into the market is changing and becoming more complex. Companies are increasingly relying on efficient-collaboration strategies between various parties involved in the entire value chain.

With the dawning of personalized medicine and the passing era of blockbuster molecules, pharmaceutical companies are slowly transforming from an industry of products to one of information. In addition, the shift to more integrated global operations, and a distributed organizational structure, make the reliance on effective collaboration tools of paramount importance. In today's rapidly evolving pharma market, firms are relying on efficient collaboration strategies in order to counter.

BioSpectrum looks at the top 10 collaborative developments that happened in the bioscience industry in India during 2012.

Biocon-Bristol-Myers Squibb (BMS)
Biocon has a long standing relationship with BMS for drug discovery and development and a dedicated discovery and development center employing over 400 scientists at the Biocon Park in Bangalore. Biocon recently extended this relationship further by partnering with BMS for global development of its novel molecule oral insulin. Biocon will progress further on global development pathways with the support from BMS expertise in taking molecules from lab to market. Dr Kiran Mazumder-Shaw, chairman and managing director, Biocon pointed out,

"The purpose of this partnership is to accelerate the progress of this novel molecule through global clinical trials under guidance from a well entrenched global player, in order to meet the unmet needs of diabetic patients across the world. Biocon's oral insulin will possibly be the first oral insulin of the world to hit the market. We are confident that with BMS' expertise available to Biocon, we will be able to take oral insulin forward on its development pathway much faster. We look forward to working closely with BMS to shape our dream into reality."

Claris-Otsuka, Mitsui joint venture
Claris Lifesciences, a pharmaceutical company in the business of manufacturing and marketing of high-end injectables, entered into a deal with Otsuka and Mitsui in the form of a joint venture for their infusion business in India and in emerging markets.
Mr Karnvir Mundrey, director, Atharva Lifesciences Consulting believes, "It is a sensible deal as historically infusion business has accounted for 55 percent of Claris' activities. The agreement constitutes common solutions, Anti-infectives, plasma volume expanders and parenteral nutrition therapies. The shareholding would be Claris-20 percent, Otsuka-60 percent and Mitsui-20 percent subject to all the necessary approvals and regulations."

Claris-Otsuka shall co-brand its products and also use the manufacturing and supply chain facilities under the deal in India and globally. Otsuka can introduce its products in Indian market. Claris will receive `1,050 crore in total by cash.

Dr Reddy's - Merck Serono
Dr Reddy's and Merck Serono partnered to co-develop a portfolio of biosimilar compounds in oncology, primarily focusing on monoclonal antibodies (mAbs) on June 6, 2012.

Mr Mundrey said, "Biosimilars are the next big thing for India after generics. Merck Serono's strength in developing, manufacturing and commercialization gives it an edge over its counter parts and Dr Reddy's banks on its global expertise in marketing generics and biosimilars. Thus, it would be an obvious option for Merck Serono for a deal with Dr Reddy's."
"Not to forget the cost savings for Merck Serono as phase-1 development is carried out by Dr Reddy's. Also, to a fruitful extent, the agreement will be a mutual benefit for both the parties as R&D will be carried out on cost sharing basis, and commercialization will be done by both parties in the US and Dr Reddy's will receive royalties. Outside the US, with the exception of some markets , where it will be co-exclusive and where Dr Reddy's maintains exclusive rights, the deal will help Dr Reddy's presence in the biosimilars space in select emerging markets and enables participation globally," he said.

Jubilant - Mnemosyne
On February 21, 2012, Jubilant entered into drug discovery collaboration with Mnemosyne Pharmaceutical to identify preclinical candidates in the area of neuropsychiatric diseases. Dr Subir Basak, president, Jubilant Biosys, said, "The collaboration covers multiple programs, which are being enabled by Mnemosyne's expertise in drug discovery and NMDA receptor pharmacology and supported by Jubilant's translational center in Malvern, Pennsylvania and by scientists from Jubilant's India-based facilities.

The collaboration is integrating the capabilities of the companies across medicinal chemistry, NMDA receptor pharmacology, electrophysiology, computational chemistry and DMPK and in vivo pharmacology as appropriate in progressing promising compounds through preclinical development.

Under the terms of the alliance agreement, Mnemosyne will exclusively own all IP generated and shall be responsible for clinical development and commercialization."

Ranbaxy - Daiichi's hybrid business model
Ranbaxy inked a deal on June 20, 2012 to launch hybrid business in Venezuela. This is a unique business model that Ranbaxy and Daiichi Sankyo started since the latter acquired Ranbaxy in 2008. This unique business model brings together the complementary strengths of a global generic company (Ranbaxy) and a top global innovator (Daiichi Sankyo). The coming together of the two entities marks a paradigm shift in how global pharmaceutical companies collaborate to serve the needs of patients effectively.

The spokesperson from Ranbaxy said, "Both Ranbaxy and Daiichi Sankyo believe this revolutionary model is best suited to cater to the changing dynamics of the global pharmaceutical industry. The combined entity now ranks among the top 20 global pharmaceutical companies."
The collaboration extends beyond marketing and covers the entire value chain including R&D, supply chain, quality and safety management, sales and manufacturing, and also CSR.

As a member of the Daiichi Sankyo group, Ranbaxy introduces Daiichi Sankyo's innovator products in the emerging and developed markets across the world. This gives Ranbaxy a distinct edge as it is among the few global generic companies offering a wide range of both generic and innovator products.

In markets where Ranbaxy is the stronger player, Ranbaxy takes the lead to promote both its own generic products, as well as Daiichi Sankyo's innovator products, irrespective of the nature of the market. In markets where Daiichi Sankyo's is stronger, it takes the lead to promote both its own innovator products and Ranbaxy's generic products.

In Venezuela, which is the third biggest market in Latin America, Ranbaxy is planning to sell its products through Daiichi Sankyo Venezuela. The deal will increase Ranbaxy's presence and also further strengthen Daiichi's presence in the area.

Ranbaxy - Gilead
Ranbaxy also entered into an in-licensing agreement with Gilead Sciences on August 3, 2012. The agreement is to promote access to cheaper generic emtricitabine and emtricitabine-containing anti-retroviral in developing countries.

Ranbaxy's six-year-old partnership with Gilead was further extended through this deal to promote access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine (FTC) in developing countries, including single tablet regimens containing emtricitabine, and fixed-dose combinations of emtricitabine co-formulated with other Gilead HIV medicines.

Panacea - Osmotica
Panacea Biotec, an Indian firm, whose three cardinal business principles have been focus on innovation, brand building and collaboration, collaborated with Osmotica Pharmaceutical, a drug delivery specialized company and brings to the collaboration an immense expertise on the regulatory and commercialization aspects of complex drug delivery based generics, in September 2012.

This strategic alliance is for the research, development and commercialization of drug delivery based high-barrier-to-entry generic and branded pharmaceutical products in the US and other key strategic markets across the globe with Osmotica. The collaboration is designed to build upon each company's highly complementary strengths and quality assets.

Panacea Biotec would lead product identification, research, development and manufacturing while Osmotica would lead product registration, legal matters, marketing, sales and distribution.

Dr Rajesh Jain, joint managing director, Panacea informed, "The collaboration products are expected to be sold under an Osmotica and Panacea Biotec label. This collaboration is based on a 50:50 risk, investment and profit sharing by both companies and starts with a portfolio of 18 products across a broad range of therapeutic categories, with a provision to add new products by the Joint Steering Committee represented by both Osmotica and Panacea Biotec."

Panacea Biotec has received a research fee from Osmotica on signing and milestone payments over the past months. Moving forward, Panacea Biotec will receive agreed amounts of milestone payments representative of 50 percent share of development costs from Osmotica on achievement of development milestones.

For every new product added to the collaboration and for each new market thereof, Panacea Biotec shall receive a fixed license fee besides receiving the 50 percent development costs. Post commercialization of the products in the US and other markets as may be added from time to time, both Panacea Biotec and Osmotica shall share the profits equally.

Panacea - Kreamers
Panacea also collaborated with Kreamers Urban, a specialty generic business subsidiary of UCB, with an exclusive focus on pharmaceutical products that have a "high-barrier-to-entry". Panacea Biotec announced the strategic alliance with Kremers Urban for 11 high-barrier-to-entry-generic products in the US market representing an opportunity of $4 billion at the innovator sales level.

The first product in this portfolio to reach the market was Tacrolimus capsules, launched in the US in November 2012. Panacea Biotec was granted approval of the product from US FDA in September 2012. This would be followed by a series of high barrier to entry generic product launches that are being developed by Panacea Biotec.

In this collaboration, Panacea Biotec would take the lead in research, development, registration and commercial supplies of products while Kremers Urban would be leading marketing, sales and distribution. The business collaboration is based on long-term profit sharing by both companies.

Dr Jain said, "The commercialization strength of Kremers Urban for high barrier to entry generics perfectly synergizes with Panacea Biotec's R&D and manufacturing capabilities for such complex products forming a true win-win strategic alliance."

Piramal - Fujifilm Diosynth Biotechnologies
Piramal Enterprises' life sciences division has over a decade history of life sciences related collaborations with companies from across the globe. Dr Swati Piramal, vice chairperson, Piramal Enterprises mentions, "For many years we entered into numerous joint ventures, acquisitions or other agreements to help foreign pharmaceutical companies to commercialize their medicines in India. However in more recent years we have broadened the scope of our collaborations to embrace a wider range of cutting edge innovations, wherever they may be located."

In October 2012, Piramal's Pharma Solutions division formed a strategic alliance with Fujifilm Diosynth Biotechnologies, Japan. Piramal partnered with Fujifilm to offer the seamless contract development and manufacture of antibody drug conjugates (ADCs), a growing niche in the development of biopharmaceuticals.

TCG - JSW
TCG Lifesciences, a leading contract research services company with operations in India, Europe, Japan and the US entered into a strategic alliance with JSW Lifesciences on November 16, 2012.

Mr Mundrey feels, "It can benefit TCG to expand its expertise in CNS and also in its drug discovery platform. TCG's quality and expertise are what have promoted JSW to partner with them. It also helps JSW to get the Indian market advantage. Thus the deal is mutually beneficial."