As the shortage of cartridges of its injectable diabetes drug Byetta reaches critical levels, Amylin Pharmaceuticals is seeking to expand manufacturing capacity and is exploring a nasal spray formulation of the medicine with drug delivery firm Nastech.
Byetta, which is derived from Gila monster saliva, causes weight loss in many patients instead of the weight gain most existing diabetes treatments bring about, and has therefore become so popular that Eli Lilly, which has co-developed and markets the drug, advised doctors earlier this month not to give out new prescriptions until manufacturing capacity can cope.
But the cartridges are currently only produced by the UK subsidiary of Indian biopharmaceutical firm Wockhardt, which has been exceeding contractual obligations to supply these cartridges in view of the shortage.
Now Wockhardt has announced it will commission in September a new UK facility to boost its Byetta cartridges manufacturing capacity fourfold.
"Our factory has been operating seven days a week to supply Byetta," Sirjiwan Singh, managing director of Wockhardt UK, said.
"We unilaterally and proactively decided to invest in new cartridge capacity."
Yet Wockhardt will not be the sole manufacturer for long, as Lilly has said that Baxter Pharmaceutical Solutions will start making the cartridges in the second half of 2006.
In addition, Amylin is determined to exploit the full potential of Byetta to dominate the global diabetes drug market, worth $15bn (€12bn) this year and projected to reach $25bn by 2011, and is in search of new formulations to take on three major competitors - Exubera, Galvus and Januvia.
Exubera, Pfizer's inhalable insulin, is expected to reach pharmacies next month, while Novartis's Galvus and Merck's Januvia, both taken as pills, are likely to be approved by the US Food and Drug Administration (FDA) by early next year.
Keen for a needle-free version of Byetta, Amylin this week recruited Nastech to develop a nasal spray formulation of exenatide, the drug's active pharmaceutical ingredient (API).
Preclinical studies of the formulation have already been completed in preparation for initiating studies to determine feasibility in human subjects and, under the agreement, Amylin will have overall responsibility for the development programme, including clinical, non-clinical and regulatory activities, while Nastech's efforts will focus on drug delivery and chemistry, manufacturing and controls activities.
Nastech stands to earn up to $89m in milestone payments, based on specific development, regulatory, and commercialisation goals, and its royalty rates will escalate with product success.
"This collaboration validates an important aspect of Nastech's business strategy, which is to conduct feasibility studies with biopharmaceutical companies and later convert them into development and commercial manufacturing collaborations," said Steven Quay, president and CEO of Nastech.
"Amylin is a leader in developing innovative therapeutics and we are very excited to work with them."
If a supply agreement is reached between the companies, Nastech may supply commercial product to Amylin and Lilly.
Amylin is also working with drug delivery firm Alkermes on a long-acting release formulation of injectable Byetta.
Byetta may be a pioneer in a new class of diabetes drugs called incretin mimetics, but the clock is ticking for Amylin to develop new formulations that will allow it to perform strongly in this competitive market.