Drug discovery has turned into a hot topic in the world’s generic powerhouse. The immediate trigger for this spurt in interest is Biocon’s recent launch of a trastuzumab biosimilar. Developed in partnership with Mylan, the ‘cost-effective’ version of the complex monoclonal antibody is touted as the first-of-its-kind substitute for breast cancer therapy Herceptin, which posted $6.4 billion in 2012 sales.

But trastuzumab is not Biocon’s first successful experiment with MAbs. In 2006, the country’s largest biotech company commercialized BIOMAb-EGFR, to treat head and neck cancer. And Biocon has already lined up another drug to treat psoriasis for launch from its MAb pipeline. Biocon has R&D alliances with innovators, including Bristol-Myers Squibb to pursue an oral version of insulin.

India’s drug discovery scene has been especially busy of late. Jubilant Biosys Ltd., an end-to-end discovery R&D services firm, announced a successful IND filing in August 2013. The novel molecule, targeting prostate cancer, was born out of the collaborative efforts of the Bangalore-based firm and U.S.-based Endo Pharmaceuticals. The CRO entered into the joint program focusing on multi-target cancer therapies with Endo in 2009. Jubilant completed the entire preclinical work for the prostate cancer drug in fewer than three years, said a company release. Jubilant Bio has also been working with Rhode Island-based Mnemosyne Pharmaceutical to identify candidates for neuropsychiatric diseases.

Milestones Upfront
Advinus and Takeda have also made headlines at the IND level. In January, Advinus Therapeutics announced that it received a $3 million payout from the Japanese drugmaker on reaching the first milestone in a three-year collaboration. The program was to discover and develop novel targets for therapeutic areas including inflammation, CNS and metabolic diseases. Promoted by Tata Group, Advinus offers development services to pharma, agro and biotech industries. With Takeda, Advinus is responsible for leading the programs to create optimal IND-ready compounds.

Similarly, TCG Lifesciences reached an exclusive research agreement with Swiss Debiopharm to develop a novel class of antibiotics in September 2013. Headquartered in Kolkata, eastern India, TCG offers early drug discovery and development solutions for therapeutic categories including CNS, inflammation and pain, metabolic disorders and infectious diseases.

Debiopharm in-licenses and co-develops biological and small molecule drug candidates in clinical development. Debiopharm’s developmental expertise combined with TCG’s capability in medicinal chemistry and efficiency in discovery operations provide an attractive opportunity for accelerated discovery of novel drug candidates for clinical development, the company said while announcing the deal.

As an increasing number of companies shift their focus to biosimilars and other protein-based therapies, CROs are also strategically realigning their services. Contract service providers are scrambling to augment their biologics capabilities, but locating good resources has become a slog. Developing mastery in specialized therapeutic proteins is usually a long-haul process. This may present a rationale for GVK Bio’s buyout of the California-based bio-CRO Aragen Bioscience.

Similars Synergy
Having established itself as a small molecule service provider, GVK Bio agreed to acquire Aragen, which specializes in high-value biologics services, in early February 2014 for an undisclosed sum. “Aragen’s scientific excellence and expertise in large-molecule R&D services, combined with GVK Bio’s scale, resources, and global reach, will create significant synergies for both companies,” stated Rick Srigley, Aragen’s president and chief executive officer.

However, there is also the news of AstraZeneca closing down its R&D center in the south Indian city of Bangalore. With a staff of 168, the facility was dedicated to finding new therapies for neglected tropical diseases, such as tuberculosis and malaria. The center developed an experimental TB drug (AZD 5847) to fight drug-resistant strains of the disease. Although AZ will discontinue research in neglected diseases, it will continue working on the TB molecule, which is currently undergoing mid-stage trials in South Africa.

According to CROs, AZ’s move to provide expertise to advance third-party research programs presents an opportunity. The trend for global pharma is to focus on core therapeutic areas and outsource the rest. AZ’s decision to shut down the R&D base is close in line with the new strategy. It underscores the fact that partnership with small research firms with proven expertise will continue to be the mantra for bigger clients in the coming days, CROs said.