Buying niche and new businesses

1 February 2012



The pharmaceutical industry’s most significant mergers and acquisitions have involved US-based companies buying smaller North American firms with expertise in niche segments and new categories, writes Manisha Das, associate project manager of GlobalData’s deals team.


The pharmaceutical industry, particularly in North America, has recorded major M&As and asset transactions. With some of the major drugs expected to lose their patents soon, pharma majors are focusing on the takeover of small biotech companies with innovative technologies and unique compounds, in the hope that they will produce biological blockbusters, and companies with expertise in niche segments and new categories. This will enable them to chart out long-term growth plans and help the pharmaceutical industry meet the needs of patients and practitioners.

Gilead acquires Pharmasset

Gilead Sciences completed the acquisition of Pharmasset for a purchase consideration of $11.2 billion, or $137 a share, in cash on 15 December 2011. The deal was announced on 21 November.

Gilead Sciences is a research-based US biopharmaceutical company that focuses on the development and commercialisation of innovative products for the treatment of life-threatening diseases. Its marketed portfolio includes 14 products focusing on HIV/Aids, liver disease, and cardiovascular and respiratory conditions. Pharmasset is a clinical stage pharmaceutical US company active in the discovery and development of novel drugs for the treatment of viral infections. It concentrates primarily on the development of oral therapeutics to treat hepatitis C (HVC).

"Pharma majors are focusing on the takeover of small biotech companies that have innovative technologies and unique compounds."

Pharmasset's HVC pipeline includes three drug candidates. The company presented promising phase II results in early November 2011, signifying the strong efficacy and safety profile of one of those candidates, the compound PSI-7977. Gilead's R&D programmes include seven new drug candidates for the treatment of HCV. Its research focuses on developing oral regimens for the treatment of the disease, irrespective of the viral genotype.

Pharmasset's drug candidates are closely related to Gilead's HCV portfolio, and the acquisition will boost Gilead's efforts to develop an oral regimen. This association is Gilead's first step towards strengthening its HCV portfolio and gaining a competitive edge in the segment. It will drive its long-term growth plans and help the company attain advancements in its HCV programmes, as well as bring about a change in the treatment of HCV-infected patients.

BMS buys out Inhibitex

Bristol-Myers Squibb (BMS) completed the acquisition of Inhibitex for a purchase consideration of approximately $2.5 billion, or $26 a share, in cash on 13 February 2012. The all-US deal was announced on 7 January. BMS is engaged in the discovery, development, licensing, manufacture, marketing and distribution of biopharmaceuticals and related healthcare products. Its principal areas of focus include cancer, psychiatric disorders, cardiovascular disorders, diabetes, hepatitis B, HIV/Aids and rheumatoid arthritis.

Inhibitex is a clinical-stage biopharmaceutical company that develops innovative products that can treat or prevent serious infections, with a focus on the development of nucleotide/nucleoside analogues for the treatment of HCV. Its lead HCV asset is INX-189, an oral nucleotide polymerase (NS5B) inhibitor in phase II development, which has exhibited potent antiviral activity, a high barrier to resistance and pangenotypic coverage. Nucleotides/nucleosides are emerging as an important class of antivirals that may play a critical role as the backbone of future direct-acting, antiviral-only combination approaches to HCV treatment.

The acquisition will enable BMS to add Inhibitex's nucleotide polymerase inhibitor to its portfolio, which includes other direct-acting antivirals, and increases the options to develop all-oral regimens with better cure rates, shorter duration of therapy and minimal toxicity. BMS will use its expertise in antiviral drug development and its existing complementary portfolio to assure the development of INX-189.

Amgen ties up Micromet

Amgen announced the acquisition of Micromet for a cash consideration of $1.2 billion, or $11 a share, on 26 January 2012. Amgen is a US-based biotechnology company that focuses on the discovery, development, manufacture and marketing of human therapeutics based on advances in cellular and molecular biology.

"The acquisition of Micromet will enable Amgem to acquire an innovative oncology asset that has global rights and a validated technology platform."

Micromet is a biopharmaceutical firm in the US, with a focus on the discovery, development and commercialisation of innovative antibody-based therapies for the treatment of cancer. The company is advancing a pipeline of novel therapeutics based on its proprietary Bispecific T-cell engager (BiTE) technology. Its lead product candidate blinatumomab is an antibody in phase II clinical development for acute lymphoblastic leukaemia. Blinatumomab is also in clinical development for the treatment of non-Hodgkin's lymphoma, and could have applications in other haematologic malignancies.

The acquisition of Micromet will enable Amgen to acquire an innovative oncology asset that has global rights and a validated technology platform with broad, potential clinical applications. Blinatumomab will serve as an important complement to Amgen's oncology pipeline, and will help the company develop and successfully commercialise therapeutics to treat patients with grievous illness. Amgen will use its extensive resources and experience for the commercialisation of blinatumomab, and will expand its development across a broader range of B-cell malignancies, as well as maximise the full potential of BiTE technology.

Alexion purchases Enobia Pharma

US company Alexion Pharmaceuticals has completed the acquisition of Canadian firm Enobia Pharma in an all-cash transaction comprising $610 million in up-front cash, and up to $470 million on achievement of various regulatory and sales milestones. The deal was announced on 28 December 2011, but was finalised on 7 February 2012.

Enobia Pharma is a clinical-stage biotech company that specialises in developing novel therapeutics for serious metabolic bone disorders. Alexion Pharmaceuticals is a biopharmaceutical firm that concentrates on serving patients with severe and ultra-rare disorders through the innovation, development and commercialisation of life-transforming medicines.

Enobia's lead product candidate, ENB-0040 (asfotase alfa), is a human recombinant-targeted alkaline phosphatase enzyme-replacement therapy for patients suffering from hypophosphatasia (HPP), an ultra-rare life-threatening genetic metabolic disease for which there are no approved treatment options.

This acquisition will enable Alexion to acquire full worldwide development and commercial rights to asfotase alfa, and bring it to HPP patients around the world. Asfotase alfa was awarded 'orphan drug' designation in the US and EU in 2008, and Fast Track status in the US in 2009, and is currently in phase II clinical development.

Celgene agrees Avila Therapeutics deal

Celgene Corporation has entered into an agreement to acquire Avila Therapeutics for an up-front purchase consideration of $350 million in cash and contingent milestone payments of $575 million.

"Enobia Pharma is a clinical-stage biotech company that specialises in developing novel therapeutics for serious metabolic bone disorders."

Celgene Corporation is a US biopharmaceutical company engaged in the discovery, development and commercialisation of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Avila Therapeutics is a clinical-stage biotechnology US firm with a focus on the design and development of targeted covalent drugs to achieve best-in-class outcomes. The company's product pipeline was built using its proprietary Avilomics platform, which focuses on cancer, viral infection and autoimmune disease.

Avila's product candidate, AVL-292, a highly selective Bruton's tyrosine kinase (Btk) inhibitor and a potential treatment for cancer and autoimmune diseases, is currently in phase I clinical testing. The acquisition, which took place on 26 January 2012, enables Celgene to expand its leading role in the future treatment of haematologic cancers. In addition, Avila's Avilomics augments Celgene's investment in the discovery and development of novel therapeutics for managing complex disorders.

The pharmaceutical industry has recorded major M&As.


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