On day two of Cowen and Company’s 39th Annual Health Care Conference, more companies shared insight into pipeline development. BioSpace rounded up a few of the stories.
On day two of Cowen and Company’s 39th Annual Health Care Conference, more companies shared insight into pipeline development. BioSpace rounded up a few of the stories.
Amgen – During a conversation with investors, David Meline, chief financial officer at Amgen, pointed to the company’s biosimilar pipeline as a potential multi-billion driver for the company. Over the past several years, Amgen has had 10 biosimilars in development, six of which are now in advanced Phase III studies or have been submitted for regulatory approval. The company has launched two biosimilars in Europe, Amgevita, a biosimilar to AbbVie’s Humira, and Kanjinti, a biosimilar to Genentech’s Herceptin. Meline said the company anticipates additional launches in the future. Earlier this year, Amgen also reported positive results from a Phase I/Phase III trial for a biosimilar to Biogen’s Rituxan.
Meline also highlighted some of the strengths of the company’s pipeline. He pointed to Omecamtiv Mecarbil, a Phase III product for heart failure and asthma treatment Tezepelumab, which is also in Phase III development. Meline also pointed to the recent approval of Evenity in Japan. The drug was approved for the treatment of osteoporosis in patients at high risk of fracture. The company is also eying potential approval in the U.S. An advisory committee with the U.S. Food and Drug Administration gave an 18 to 1 favorable vote for the medication. Meline also pointed to the company’s BiTE molecules in development, including AMG 420 or BCMA BiTE for multiple myeloma.
Meline said the company is “positioned very nicely for long-term growth.”
Bristol-Myers Squibb –As Bristol-Myers Squibb continues to move forward with its acquisition of Celgene, BMS CEO Giovanni Caforio and other executives fielded numerous questions about the deal. During a Q&A, Cowen’s Stephen Scala said the company is consistently asked two questions about the merits of the acquisition and whether or not a series of smaller acquisitions would not have been better for BMS than the $74 billion deal for Celgene. Scala said it’s important to give some thought to Caforio’s argument that acquiring Celgene will be transformative for the company and was done so from a position of strength.
Caforio said the deal for Celgene, struck in January, “is the right option and the best option for Bristol-Myers Squibb.” Caforio said the deal creates a strong company that is well-positioned for long-term and sustainable growth. He said he is clear about the strategic rationale for the deal and his board of directors understands their fiduciary duties.
BMS executives were also clear that they performed their due diligence when it comes to the intellectual property of Celgene, particularly as it relates to that company’s top-selling drug Revlimid. Revlimid brought in nearly $10 billion last year for Celgene, but it will be facing patent challenges in the next several years, which will cause it to lose revenue-driving steam.
A shareholder vote that will finalize the acquisition is set for next month, April 12.
Amarin Corporation – John Thero, president and CEO of Amarin Corporation said things seem to be getting more dire in the cardiovascular space as it relates to public health burdens. In November, Ireland-based Amarin released data that showed its fish-oil-based drug Vascepa reduced the relative risk reduction of adverse cardiovascular events by 25 percent, including a 20 percent reduction in cardiovascular death. Trial data showed that patients receiving Vascepa in addition to statin therapy saw a risk reduction of 31 percent to experiencing a heart attack, a 28 percent risk reduction for stroke, and a 20 percent risk reduction in CV-related death.
Vascepa has already been approved to treat patients with triglyceride levels higher than 500 milligrams per deciliter, triple normal levels. Results from the REDUCE-IT study will be used as an attempt to expand the labeling indication for the drug, Thero said.
“We are on track for soon submitting a sNDA to the FDA seeking a label expansion from our current triglyceride lowering indication to one for a prevention of cardiovascular events beyond cholesterol management,” Thero said.
