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March 10, 2016 By Mark Terry , BioSpace.com Breaking News Staff With increasing competitor pressures and facing numerous patent cliffs, Thousand Oaks, Calif.-based Amgen has been straightforward about its interest in a possible merger or acquisition this year. Once that news broke, all eyes turned toward what companies Amgen might target. Here are three possibilities. Alnylam Pharmaceuticals Cambridge, Mass.-based Alnylam Pharmaceuticals is currently developing ALN-PCSsc, to cut cholesterol levels. Amgen made an entry into the cardiovascular market with the launch of Repatha, a PCSK-9 inhibitor. In July, Repatha (evolocumab) was approved for use in Europe, and in August approved for use in the U.S. Aliya Kaleem , writing for BidnessEtc., says, “To strengthen its position in the cardiovascular therapeutic area, Alnylam Pharmaceuticals could be Amgen’s best bet. The $5 billion drug maker is developing a cholesterol-lowering treatment, called ALN-PCSsc, which reduces bad cholesterol levels in patients by more than 50 percent. Moreover, the treatment proved to be effective for a relatively long period of six months.” Alnylam hopes to launch the drug in 2017. Scooping it up would expand Amgen’s foothold in this market while eliminating a potential competitor. Incyte Corporation Wilmington, Del.-headquartered Incyte Corporation primarily focuses on the oncology sector. Amgen has a strong presence in oncology, but is facing a number of patent expirations and competition from biosimilars. Incyte has a current market value of about $13 billion. Its only approved drug is Jakafi, which accounts for 70 percent of company revenue. It’s expected to be a blockbuster drug by 2020. The company also has nine cancer drugs in its pipeline, three of which are JAK inhibitors. The company has also been cited as a possible acquisition target of Shire . Kaleem writes, “Moreover, the current market weakness makes Incyte an even more attractive option for Amgen. The drug maker has lost roughly 40 percent of its share price this year and 46 percent since the healthcare sell off began in September. Incyte currently trades near its 52 week low, and thus presents a golden opportunity for an acquisition deal.” Ligand Pharmaceuticals La Jolla, Calif.-based Ligand Pharmaceuticals would be a potential smaller deal for Amgen. Ligand has a diverse portfolio in oncology, inflammatory diseases, and metabolic conditions, as well as others. The company has made quite a number of licensing partnerships this year already. In January, Ligand announced it had inked a worldwide license agreement with Emergent BioSolutions Inc. . Emergent will use Ligand’s OmniRat, OmniMouse and OmniFlic technologies to discover human mono- and bispecific antibodies. Ligand will be eligible for access payments, patent filing fees, and potential milestone payments and royalties. On Feb. 2, Ligand announced it had signed a global license deal with Tizona Therapeutics Inc. Again, Tizona will use the OmniRat, OmniMouse and OmniFlic platforms to generate antibodies, with various patent fees and milestone payments possible. Amgen currently focuses on oncology/hematology, bone health, inflammation and nephrology. In addition, two newer areas are cardiovascular—with its launch of Repatha—and neuroscience. In September 2015, Amgen signed a collaboration deal with Switzerland-based Novartis to develop and commercialize neuroscience drugs. They’re working on Novartis’s CNP520 for Alzheimer’s disease, and Amgen’s AMG 334, which is in Phase III trials for migraine headaches, and AMG 301, which is in Phase I for migraine. Besides Repatha in the cardiovascular arena, Amgen presented data in November 2015 from a Phase II trial in conjunction with South San Francisco firm Cytokinetics Inc. . They were evaluating omecamtiv mecarbil in patients with chronic heart failure. But three companies are only the tip of the iceberg where Amgen is concerned. The company’s David Picquad , senior vice president of business development, recently told Bloomberg that his team evaluates about 3,000 opportunities each year ranging from small academic licensing options to major acquisitions. Although analysts and investors seem to feel that Amgen has money just burning a hole in its pocket to be spent, the company has shown restraint in last year’s frenzied market and is likely looking for the right fit.

March 8, 2016 By Mark Terry , BioSpace.com Breaking News Staff Thousand Oaks, Calif.-based Amgen hinted recently that its interest in a merger and acquisition is real, and that its earlier stated intention of a deal in the $10 billion range may be low. It’s no particular secret that Amgen is looking at a deal, after having sat on the bench during 2015’s merger and acquisition frenzy . In November 2015, company insiders told The Financial Times the company was evaluating acquisition targets in the $10 billion range with a particular focus on companies that have drugs that are close to market. The last major deal by Amgen was the acquisition of Onyx Pharmaceuticals, Inc. in 2013 for about $10 billion. As part of that deal, Amgen acquired the rights to oncology drug Kyprolis. That drug’s sales were initially quite modest, which gave investors numerous opportunities to second-guess Amgen’s strategy. But in 2014, the U.S. Food and Drug Administration (FDA) approved Kyprolis for use in a cocktail of treatments for relapsed multiple myeloma, then in September 2015, the FDA accepted a supplemental New Drug Application (sNDA) for Kyprolis in patients with relapsed multiple myeloma. As a result, Kyprolis sales have increased 46 percent year-over-year. And the company’s other drugs are doing well, with Enbrel sales rising 30 percent, Neulasta increasing 6 percent, Xgeva popping 19 percent, Sensipar/Mimpara improving 19 percent, and Prolia increasing 25 percent. Amgen’s chief financial officer, David Meline , recently sat down for an interview with BloombergBusiness, where he noted that the company has more than $30 billion in cash and equivalents, and the key to a merger is patience. He said the company is now “more energetic about being out there,” but last year declined a few deals that weren’t a perfect match. “The hardest thing to do when you have money in the bank is to be disciplined.” Part of its merger-and-acquisition strategy involves expanding into two new areas, cardiovascular and neuroscience. In September 2015, Switzerland-based Novartis announced a collaboration deal with Amgen to develop and commercialize neuroscience drugs. They’ve agreed on several compounds, including Novartis’s CNP520 for Alzheimer’s disease and Amgen’s AMG 334, in Phase III trials for migraine, and AMG 301, which is in Phase I for migraine. Novartis, for the migraine program, obtained global co-development and commercial rights outside the U.S., Canada and Japan. In November 2015, Amgen also presented data regarding a Phase II trial in conjunction with South San Francisco firm Cytokinetics Inc. of omecamtiv mecarbil in patients with chronic heart failure. The drug met is primary pharmacokinetic objective, showing statistically significant improvement in all pre-specified secondary measures of cardiac function. In July, Amgen’s drug for uncontrolled cholesterol, Repatha (evolocumab) was approved for use in Europe. A month later, the FDA approved it for use in the U.S. The other four categories that Amgen focuses on are oncology/hematology, bone health, inflammation and nephrology. Despite the success of Kyprolis, it faces a number of patent expirations in its cancer lineup, including Neulasta, Neupogen and Epotin Alfa. In 2014, those drugs made up $7.8 billion of Amgen’s revenue, almost 40 percent. By 2020, analysts project that its cancer drug revenue will drop to $5.3 billion. And Novartis AG ADR’s Sandoz has launched a biosimilar to Neupogen called Zarxio. So analysts are checking their crystal balls, trying to predict which companies—and type of companies—Amgen will target. David Picquad , Amgen’s senior vice president of business development, told Bloomberg that his team considers about 3,000 opportunities each year ranging from small academic licensing options to major acquisitions. He cites the need to balance internal research with acquired innovation. “Companies trying to do it all internal might hit a dry patch, while those rolling up more and more and more companies can’t sustain it,” Picquad told Bloomberg. “The virtuous approach is to do a bit of both.”