By Randall Osborne
West Coast Editor
Two delivery firms with experience aplenty helping other companies get drugs into patients ¿ Alkermes Inc. and Bioject Medical Technologies Inc. ¿ have teamed up in a development deal to advance the former¿s own compounds.
Under the terms, Portland, Ore.-based Bioject is joining Alkermes, of Cambridge, Mass., to develop up to three drugs as products for Alkermes, using Bioject¿s Iject, along with possibly other of the firm¿s needle-free systems.
¿We¿ve been quietly transforming the company over the last two years, and this deal is representative of that,¿ said James Frates, vice president and chief financial officer of Alkermes, which will provide monthly payments to Bioject, adding cash as milestones are met. A commercial supply agreement for Iject is included in the deal. Other financial details were not disclosed.
Bioject¿s needle-free injection forces medication at a high speed through the skin, thus depositing it into the tissue.
Frates told BioWorld Today that Alkermes, even as it serves its partners, has been taking aim at drug development, using off-patent (which Frates prefers to call ¿multisourced¿) compounds and others already approved or in development by partner firms.
¿That¿s exactly what Alza did,¿ Frates noted, citing New Brunswick, N.J.-based Johnson & Johnson¿s buyout of Alza Corp., of Mountain View, Calif., in a deal with a net equity estimated at $10.5 billion. ¿And a major reason they bought [Alza] was for the two drugs developed using their drug delivery systems,¿ he added. (See BioWorld Today, March 28, 2001.)
Frates declined to say which drugs are the targets of the Bioject deal. ¿We haven¿t disclosed anything about that,¿ he said.
Alkermes and Bioject already are working with major-league partners. Less than a year ago, Bioject entered a development and supply deal with Amgen Inc., of Thousand Oaks, Calif., centered on Iject for undisclosed indications. Amgen made a $1.5 million equity investment in Bioject, and agreed to as much as $3.1 million more. (See BioWorld Today, March 2, 2000.)
Alkermes has been in the news even more. Earlier this year, the firm signed its second deal with Indianapolis-based Eli Lilly and Co. for the AIR pulmonary delivery system, used with short-acting and long-acting insulin. Human growth hormone was the subject of the first deal, last year. (See BioWorld Today, April 3, 2001, and Feb. 9, 2000.)
¿We continue to make good progress, but we leave disclosures up to them,¿ Frates said.
In another pact, with GlaxoSmithKline plc, of London, Alkermes last month reported finishing the first clinical trial in the plan to develop advanced formulations of GSK¿s respiratory drugs.
¿The key there is, we have a broad collaboration, and they made the decision to go on to a Phase IIa trial,¿ Frates said. ¿We¿d been quiet about it for a long time, and this could be very important for us, if things continue to go well.¿
Alkermes¿ Medisorb technology, which encapsulates the drug in polymer microspheres, was the subject of a deal with Janssen Pharmaceutica Products LP, a unit of Johnson & Johnson, which filed with the FDA for approval of a long-acting injectable formulation of the antipsychotic Risperdal, also last month.
¿It¿s the first atypical antipsychotic that¿s had an NDA filed, so that¿s an important milestone for us,¿ Frates said. ¿Those are very effective drugs, the costs of non-compliance in schizophrenia are high, and the opportunity to give [Risperdal] as a long-acting agent is going to give physicians and patients more choices.¿
In August, Amylin Pharmaceuticals Inc., of San Diego, reported with Alkermes promising results from an initial safety study in healthy volunteers with multiple long-acting release (LAR) formulations of Amylin¿s drug candidate, AC2993 (synthetic exendin-4), for Type II diabetes.
¿That¿s a higher-risk program, obviously, because exendin is unapproved, let alone the long-acting form of it,¿ Frates said, adding that Amylin is ¿doing important work in this field.¿
With a J&J deal already in hand, and considering the Alza buyout, is Alkermes looking for a takeover, too?
¿We¿re a fiduciary, and we do what¿s best for the shareholders,¿ Frates said. ¿We have a great agenda, and we¿re focused on that.¿
Alkermes¿ stock (NASDAQ:ALKS) closed Tuesday at $23.58, up 18 cents. Bioject¿s shares (NASDAQ:BJCT) ended the day at $13, up $1.95, or 17.7 percent.