Lilly to Acquire Alnara Pharmaceuticals
Alnara's Pancreatic Enzyme Replacement Therapy, Liprotamase, Currently Under FDA Review
INDIANAPOLIS and CAMBRIDGE, Mass., July 2 /PRNewswire-FirstCall/
-- Eli Lilly and Company (NYSE:LLY)
and Alnara Pharmaceuticals, Inc. today announced they have signed a
definitive merger agreement whereby Lilly will acquire Alnara, a
privately held biotechnology company developing protein
therapeutics for the treatment of metabolic diseases. Alnara's lead
product in development is liprotamase, a non-porcine pancreatic
enzyme replacement therapy (PERT). Liprotamase is under review by
the U.S. Food and Drug Administration for the treatment of exocrine
pancreatic insufficiency (EPI). Causes of EPI include cystic
fibrosis, chronic pancreatitis, pancreatectomy and other
conditions.
Patients with pancreatic insufficiency cannot properly digest
and absorb fat, protein, and carbohydrates -- preventing adequate
nutrient absorption. PERT is a treatment involving the
administration of three pancreatic enzymes. EPI often is associated
with cystic fibrosis, a life-threatening genetic disorder.
Cystic fibrosis affects approximately 30,000 children and adults
in the United States and nearly 100,000 people worldwide.
Approximately 90 percent of cystic fibrosis patients receive
pancreatic enzyme replacement therapy to improve nutritional status
and bowel-related symptoms related to pancreatic
insufficiency.
Financial terms of the agreement are not being disclosed. The
transaction is contingent upon clearance under the
Hart-Scott-Rodino Antitrust Improvements Act and other customary
closing conditions. J.P. Morgan Securities Inc. acted as the
exclusive financial advisor to Alnara Pharmaceuticals and
WilmerHale is serving as legal advisor to Alnara
Pharmaceuticals.
"The acquisition of Alnara provides Lilly with a promising entry
into enzyme replacement therapy -- an area with unmet medical needs
as well as opportunities for novel compounds that give patients
additional treatment options," said Bryce Carmine, executive vice
president of Lilly and president of Lilly BioMedicines. "Alnara has
been very successful in the development of liprotamase -- as
indicated by its recent submission to the FDA -- and we look
forward to partnering with Alnara's experts during the regulatory
review process."
Alexey Margolin, Ph.D., chief executive officer of Alnara, said:
"Our agreement with Lilly is an important development as we move
liprotamase through FDA regulatory review. Lilly's deep expertise
in the U.S. pharmaceutical business, including regulatory affairs
and the development of innovative compounds that address unmet
medical needs, created a natural fit and could allow for
opportunities in markets beyond cystic fibrosis. We look forward to
finalizing the transaction and working together on next steps to
bring liprotamase to patients."
If approved, liprotamase will allow many patients to use
significantly fewer pills compared to current treatment options.
Treatments in the PERT class reduce malabsorption and enhance
nutrition in patients with EPI. Because it is not derived from a
porcine source, liprotamase could provide the added benefit for
patients of reduction in the risk of viral exposure. A pediatric
formulation of liprotamase also is in development.
About Liprotamase & Pancreatic Enzyme Replacement Therapy
(PERT)
Liprotamase is an oral, non-porcine pancreatic enzyme
replacement therapy designed to treat maldigestion, malabsorption
and malnutrition as a result of exocrine pancreatic insufficiency
associated with cystic fibrosis, chronic pancreatitis, pancreatic
cancer, pancreatectomy and other pancreatic diseases. Patients with
pancreatic insufficiency cannot properly digest and absorb fat,
protein, and carbohydrates preventing adequate nutrient absorption.
PERT is a treatment involving the administration of pancreatic
enzymes, which in the case of liprotamase includes protease,
amylase and lipase.
Results from an international, Phase 3 open-label, long-term
safety study presented at the North
American Cystic Fibrosis Conference in October, 2009
demonstrated the safety and nutritional benefits of liprotamase.
The nutritional parameters measured during the study showed
nutritional maintenance relative to the U.S. population, as well as
a significantly reduced pill burden.
About Alnara
Alnara Pharmaceuticals, Inc. is dedicated to developing and
commercializing novel protein therapeutics for the treatment of
metabolic diseases. The company's innovative approach focuses on
designing effective protein therapies that can be orally delivered
directly to the gastrointestinal tract without being absorbed into
the bloodstream. Alnara's lead product is liprotamase, a novel,
non-porcine pancreatic enzyme replacement therapy, which has
completed Phase 3 clinical development in collaboration with the
Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) and is
currently under review by the FDA. The company is committed to
bringing breakthrough new treatments to patients with unmet medical
needs. Alnara was co-founded in 2008 by Alexey Margolin, Rich
Aldrich and Christoph Westphal. Based in Cambridge, Massachusetts,
Alnara is backed by an experienced management team and top-tier
venture investors, including Third Rock Ventures, Frazier
Healthcare, MPM Capital, Bessemer Venture Partners and Longwood
Founders Fund. For more information, please visit the company's
website at www.alnara.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Ind., Lilly provides answers - through medicines
and information - for some of the world's most urgent medical
needs. Additional information about Lilly is available at
www.lilly.com. C-LLY
This press release contains forward-looking statements about the
benefits of a merger between Lilly and Alnara and the potential of
Alnara's product pipeline. It reflects Lilly's and Alnara's current
beliefs, assuming that the transaction is successfully closed;
however, as with any such undertaking, there are substantial risks
and uncertainties in the process of implementing the transaction
and in drug development. There is no guarantee Lilly will realize
the expected benefits of the transaction, or that liprotamase will
be approved by the FDA on the anticipated timeline or at all, that
liprotamase will be commercially successful, or that Alnara's
pipeline will yield commercially successful pharmaceutical
products. For further discussion of these and other risks and
uncertainties, please see Lilly's latest Form 10-Q filed April 2010
and Form 10-K filed February 2010. The companies undertake no duty
to update forward-looking statements.
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Source: Eli Lilly and Company
CONTACT: Mark E. Taylor (Lilly), +1-317-276-5795; Robert
Gallotto
(Alnara Pharmaceuticals), +1-617-349-3690; or Andrea Johnston,
Pure
Communications (for Alnara), +1-910-616-5858
Web Site: http://www.lilly.com/
Posted: July 2010
