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Tuesday, Feb 27, 2024

FDA, Investors Deal Amylin Pharmaceuticals Another Blow

The FDA’s rejection of data from diabetes drug developer Amylin Pharmaceuticals last week sent shares of the already battered stock down again, to close at their lowest point since September 2001.

Shares of Amylin, traded under the symbol AMLN on Nasdaq, fell 26 percent Nov. 4 to close at $7.94. The stock went up 13 percent the next day to close at $8.97. Its 52-week range was $6.90 to $42.46.

Federal regulators said data from studies at two manufacturing plants failed to meet “comparability” requirements.

In a filing with the Securities and Exchange Commission, Amylin and partner Alkermes said versions of their once-weekly diabetes drug Byetta used in clinical trials and made at Alkermes’ manufacturing facility were not equal to those made at Amylin’s Ohio manufacturing facility.

Amylin’s shares have taken a beating since it reported in August that six patients taking Byetta had died with pancreatitis, an inflammation of the pancreas. The company has maintained that patients with diabetes have an increased risk of the condition, and that the occurrence of pancreatitis in patients taking Byetta was no different than the usual rate of occurrence.

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Deal Worth Up To $473M:
Shares of San Diego-based Lpath spiked 31 percent Oct. 29 following news of a deal it signed with Merck Serono, a subsidiary of Merck KGaA of Germany, worth up to $473 million.

Shares of Lpath, traded over the counter under the symbol LPTN, closed at $1.30, up 29 cents.

The company is engaged in an emerging area of science whereby bioactive lipids are targeted to treat human diseases.

“It’s an emerging frontier of drug discovery; almost everybody else is focused on proteins and DNA that comes from proteins,” said Lpath CEO Scott Pancoast.

The company is conducting early stage studies in the areas of cancer and eye disease.

Under terms of the agreement, Merck will partner with Lpath to develop and commercialize an experimental drug for the treatment of various cancers, including colorectal, kidney and ovarian.

Merck will provide Lpath with up to $23 million upfront to support the company’s completion of Phase 1 studies of Asonep, the company’s lead drug candidate.

Asonep works to block a bioactive lipid, called S1P, known to promote the growth of tumors. S1P has also been studied for its involvement in drug resistance across a wide array of tumor types.

Merck will pay Lpath $28 million if it decides to develop the drug beyond Phase 1 studies. Lpath could garner additional payments of up to $422 million based on certain developmental, regulatory and sales milestones.

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New Life:
A merger between scientific instrument makers Invitrogen and Applied Biosystems will create a new business named Life Technologies, the companies said Nov. 4.

The stock will trade on Nasdaq under the symbol LIFE.

Invitrogen agreed to buy Applied Biosystems in June for $6.4 billion in cash and stock. At the time, the companies said they would operate under the name Applied Biosystems.

Send biotechnology news to Heather Chambers, hchambers@sdbj.com.


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