Eli Lilly is looking to its pipeline to fill the gaps left by a number of high-profile drugs comping off patent. In October 2011, blockbuster Zyprexa will fall to generic competition; additionally, about three-quarters of Lilly’s current revenue comes from eight drugs that will lose patent protection between now and 2017. ”We have the challenge of replenishing our product portfolio from our pipeline,” says CEO John Lechleiter in a USA Today interview. “Fortunately, we have the most exciting pipeline today in our history.”

The CEO notes that Lilly has about 70 molecules in clinical development, giving the drug giants multiple shots on goal. He adds the company is ”confident that while not all those will make it, many of them will.” Late-stage programs include enzastaurin (cancer), IMC 11F8 (non-small cell lung cancer), IMC-1121B (breast and gastric cancer), tasisulam (melanoma), teplizumab (diabetes), GLP-1 Fc (diabetes), semagacestat (Alzheimer’s) and solanezumab (Alzheimer’s), according to the company’s website. Three additional drugs are under FDA review. Lechleiter adds that aside from the Prozac expiration in 2001, Eli Lilly has gone almost 20 years without a major patent expiration. ”I think that makes the nature of the challenge more acutely felt for us.”

ALSO: Lilly has completed its acquisition of Alnara Pharmaceuticals, which is developing protein therapeutics for the treatment of metabolic diseases. The financial details were not release when the deal was first announced, but Lilly has revealed that it is paying $180 million up front and up to $380 million for the developer.

Source: FierceBiotech

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Recombinant oral therapy comprises lipase, protease, and amylase.

Lilly is buying Alnara Pharmaceuticals in order to get a foothold in the enzyme replacement therapy market. The acquired firm’s lead product liprotamase is an oral, nonporcine pancreatic enzyme replacement therapy (PERT), which is currently under FDA review for the treatment of exocrine pancreatic insufficiency.

“The acquisition of Alnara provides Lilly with a promising entry into enzyme replacement therapy,” commented Bryce Carmine, executive vp of Lilly and president of Lilly BioMedicines. “Alnara has been very successful in the development of liprotamase, as indicated by its recent submission to FDA, and we look forward to partnering with Alnara’ experts during the regulatory review process.”

Liprotamase comprises the digestive enzymes lipase, protease, and amylase, and is produced using recombinant technology. It has been formulated so patients need only take 1–2 small capsules per meal or snack, Alnara states.

The firm’s process development and production partner for liprotamase is Lonza, which has provided the microbial fermentation, process optimization, technical, and regulatory support for generating the product. Lonza is manufacturing Liprotamase at its FDA-registered facility in the Czech Republic.

The development of liprotamase over the last 12 months has been carried out by Alnara in collaboration with Cystic Fibrosis Foundation Therapeutics, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation (CFF). The product was acquired by Alnara from the Cystic Fibrosis Foundation (CFF) in 2009, which earlier the same year had taken the product over from Altus Pharmaceuticals.

The clinical development program for liprotamase included some 500 patients with exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis or pancreatectomy. Alnara claims the Phase II and Phase III clinical trials represent the largest body of prospective clinical data for any pancreatic enzyme, with both pivotal efficacy trials demonstrating that the treatment significantly improves both fat and protein absorption.

Source: GEN

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