Cystic Fibrosis

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Cystic Fibrosis

• Genetic disease mutation in the
• CFTR chloride
  channel
• Affects mainly lungs
• digestive system,

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What is cystic fibrosis?

• Mucus - lubricates and protects the linings of
  the airways, digestive system, reproductive
  system, and other organs and tissues
• In CF patients, the body produces mucus that is
  abnormally thick and sticky. This abnormal mucus
  can obstruct the airways, leading to severe
  problems with breathing and bacterial infections
  in the lungs.
• Over time, mucus buildup and infections result
  in permanent lung damage, including the formation
  of scar tissue (fibrosis) and cysts in the lungs.

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What is cystic fibrosis?

• Most people with cystic fibrosis also have
  digestive problems because thick, sticky mucus
  interferes with the function of the pancreas.
• The pancreas is an organ that produces enzymes
  that help digest food. In people with cystic
  fibrosis, mucus blocks the ducts of the pancreas,
  preventing these enzymes from reaching the
  intestines to aid digestion.

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How common is cystic fibrosis?

• Cystic fibrosis is a common genetic disease
  within the Caucasian (white) population in the
  United States.
• The disease occurs in 1 in 2,500 to 3,500
  Caucasian newborns. Cystic fibrosis is
• Less common in other ethnic groups, affecting
  about 1 in 17,000 African Americans and 1 in
  31,000 Asian Americans.

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Therapies for Cystic Fibrosis

• Dornase Alfa (Inhalation) -Helps to improve
  breathing and reduce the chance of lung
  infections. Its a Dnase
• BRAND NAME(S) Pulmozyme DNase
  Recombinant Human Deoxyribonuclease
• Acetylcysteine (Inhalation)
• Dissolves mucus so that it may be coughed up.
• Given by Inhalation
• Solution (U.S. and CanadA
• Azithromycin-antibiotic used to treat certain
  infections caused by bacteria
• BRAND NAME(S) ZithromaxPancrelipase (Oral)
• Pancrelipase-
• Enzyme that helps digest foods for patients who
  have cystic fibrosis and digestive disorders.
• BRAND NAME(S) Pancrease, Cotazym, Creon,
  Entolase, Festal II, Pancote, Viokase,
  Zymase, Ku-Zyme HP

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Who is SourceCF?

• SourceCF, founded in July 2001 by former Johnson
  Johnson executives Walters and Norm Stanley,
  began as a company that provided marketing and
  promotion services for companies that offer
  treatments and other products for the 30,000
  sufferers of cystic fibrosis,.
• SourceCF offers expertise in digestive care,
  anti-infectives, nutritionals, and pulmonary
  management equipment.

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• Today, SourceCF represents a comprehensive suite
  of quality pharmaceutical and medical products
  that include
• a highly efficient electronic nebulizer
• that delivers extremely fast treatments,
• eFlow SCF, from PARI
• anti-infective drugs from X-GEN Pharmaceuticals
  (formerly Pharma-Tek) of Elmira, New York,
• portable chest wall oscillation vest system,
  SmartVest, from Electromed of New Prague,
  Minnesota.
• In addition, SourceCF has developed a
  multivitamin line
• easy to Softgels for adults,
• good tasting bubble gum flavored
• easily tolerated citrus flavored Pediatric Drops
  for infants

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A Little Bit of History-2003

• Huntsville Biotechnology Center held its grand
  opening on Thursday.
• SourceCF Inc., Applied Genomics Inc. and Open
  Biosystems Inc. are separate companies that now
  share phone systems, computer resources,
  conference rooms .
• "It gives us the ability to share ideas,
  equipment and resources, things that small
  companies have to do to survive," said Rob Seitz,
  Applied Genomics CEO and president.
• Each company in the center is involved with a
  different aspect of biotechnology
• Walters(president of SCF) also announced Thursday
  the formation of SourceCF Clinical Research and
  Development. That company will work with CF
  groups to identify and bring promising drugs
  being worked on in labs around the world to
  market, Walters said. SourceCF is working on
  three drugs, he said.

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2007 Eurand Pharmaceuticals, Inc. has acquired
the SourceCF family of companies (SourceCF) for
6.6 million in cash

• The acquisition of SourceCF also provides Eurand
  with a U.S. based specialty sales force comprised
  of 15 highly-experienced sales and sales support
  professionals dedicated to the CF community.
• SourceCF supports the care delivered through the
  100 plus CF treatment centers located across the
  U.S. Eurand intends to integrate the SourceCF
  team into its U.S. commercial organization to
  support the planned launch of its lead product
  candidate, ZentaseTM (EUR-1008).
• Michael Walters, President of SourceCF, will join
  Eurand as Executive Vice President of Eurand
  Pharmaceuticals, Inc. He will be responsible for
  the Company?s U.S. sales and marketing efforts
  and for the launch of Zentase.

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Eurands Controlling Drug Release
(CDR)Technology Platform

• We have four technologies
• within this platform and can
• choose the best technology
• to achieve the most
• efficacious plasma
• concentration profile for
• a given therapeutic agent.
• We seek to address the specific
• needs of a compound such as reduced
• drug dosage, enhanced therapeutic
• effect and optimized safety and
• toxicity profiles.

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Eurands Controlling Drug Release
(CDR)Technology Platform
Technology
Product

• Our Diffucaps - system that provides optimal
  release profiles for either single drugs or for a
  combination of drugs.

• EUR-1000
• Collaboration PartnerReliant Pharmaceuticals,
  Inc
• IndicationHypertension, Migraine
• StatusPhase III
• rofile EUR-1000 - AB rated generic product to
  Inderal LA, a long-acting formulation of
  propranolol that is indicated for the treatment
  of hypertension and migraines. In 2005, Inderal
  LA generated approximately 215 million in sales
  according to IMS Health. EUR-1000 uses our
  Diffucaps technology.

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Eurands Controlling Drug Release
(CDR)Technology Platform
Technology
Product

• AdvaTab
• AdvaTab tablets disintegrate rapidly in the
  mouth, typically in less than 30 for convenient
  oral drug administration without water. suited to
  those patients that experience difficulty in
  swallowing capsules and tablets.
• It can be combined with Eurands complimentary
  particle technologies its world leading
  Microcaps taste-masking technology and its
  Diffucaps controlled release technology.
• Diffucaps

• EUR-1048
• Collaboration Partner
• GlaxoSmithKline (GSK)
• IndicationUndisclosed
• StatusBiostudy
• Profile Dont say anything meaningful on their
  website

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Technology
Product

• Diffucaps - system

• EUR-1025
• Collaboration PartnerEurand
• Indicationanti emetic
• StatusPhase I
• profileEUR-1025 is a once-a-day oral formulation
  of ondansetron, an anti-emetic, or agent to
  prevent nausea and vomiting, sold under the brand
  name Zofran by GlaxoSmithKline. Zofran is
  currently administered two, three and four times
  per day and had worldwide sales of approximately
  2.0 billion, approximately half of which were
  for the oral dosage form.

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Lead Product Candidate EUR-1008

• Indication Exocrine Pancreatic Insufficiency
  (EPI)
• EPI is a deficiency of digestive enzymes normally
  produced by the pancreas. These digestive enzymes
  are normally used to assist the digestion of
  food.
• EPI results from - cystic fibrosis (CF), chronic
  pancreatitis, pancreatic cancer, cytomegalovirus
  infection and HIV/AIDS. Can also result from
  surgical procedures.
• A normally functioning pancreas secretes eight
  key enzymes required for efficient digestion and
  absorption of food. In addition to these key
  digestive enzymes, several coenzymes and
  cofactors are also required.
• Marketed PEPs Porcine-derived PEPs are
  practically identical in composition to human
  pancreatic secretions and contain all of the key
  enzymes, coenzymes and cofactors necessary for
  proper digestion.
• Zentase is designed as a replacement product for
  these missing enzymes and is designed to restore
  and maintain digestion, absorption and to promote
  normal growth in these patients.

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• Eurand has completed two phase III clinical
  trials on Zentase and submitted an NDA for this
  product in December 2007. The FDA has granted
  Zentase 'Priority Review. (usually takes 10
  month, here 6 month)

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Eurand-s1

• Patients with EPI are treated with
  porcine-derived pancreatic enzyme products, or
  PEPs. According to IMS Health Incorporated, PEPs
  generated approximately 720 million in worldwide
  sales in 2005.
• PEPs have been utilized since before the
  enactment of the U.S. Federal Food Drug and
  Cosmetic Act, or FDCA, in 1938, and,
  consequently, none of the currently available
  products are marketed under a new drug
  application (NDA) approved by the FDA. In April
  2004, the FDA mandated that all manufacturers of
  EPI drug products file a NDA and receive approval
  for their products by April 2008 or be subject to
  regulatory action.

NDANew Drug Application(since 1983). The NDA
application is the vehicle through which drug
sponsors formally propose that the FDA approve a
new pharmaceutical for sale and marketing in the
U.S. The data gathered during the animal studies
and human clinical trials of an Investigational
New Drug (IND) become part of the NDA.
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Eurand-s1

• Pancreatic enzyme products are inherently
  unstable and thus, to compensate for enzyme
  degradation over time, all manufacturers
  currently include an overfill of enzymes in the
  finished product. As a result, patients receive
  PEPs with variable and uncertain levels of
  potency, resulting in an inconsistent therapeutic
  effect.
• In April 2006, the FDA issued Guidance for
  Industry addressing, among other matters, the
  elimination of overfill, the nature of clinical
  trials to be conducted to obtain FDA approval for
  a NDA, the formulation requirements for the
  product and the need for manufacturers to provide
  viral inactivation results and full
  characterization of the enzymes in the product.
  Because of the complex nature of these products,
  we believe that some of the companies currently
  marketing PEPs in the United States may not be
  able to satisfy the FDA's NDA requirements by
  April 2008. We believe this will present
  EUR-1008, if approved, with a significant market
  opportunity.
• We have designed EUR-1008 to meet the FDA
  requirements for pancreatic enzyme products.
  EUR-1008 is a highly stable formulation
  containing eight key porcine-derived enzymes and
  a number of coenzymes and cofactors that we
  believe are necessary for proper digestion. We
  believe that due to its novel formulation
  EUR-1008 will have advantages over the current
  EPI products

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Eurand-s1

• If we receive FDA approval to market EUR-1008
  in the United States, we intend to commercialize
  this product ourselves(they bought sourceCF ) by
  establishing a specialty sales and marketing
  organization that will target the approximately
  115 Cystic Fibrosis Treatment Centers (that
  sourceCF is connected to) and selected
  gastroenterologists and pulmonologists

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Risks Related to Our Business

• delays in obtaining, or a failure to obtain and
  maintain, regulatory approval for our product
  candidates, including our lead product candidate,
  EUR-1008
• The possibility that the FDA may not remove
  existing PEPs from the U.S. market that do not
  receive approval for NDAs by the April 2008
  deadline- BIG risk factor
• our ability to commercialize EUR-1008 and
  effectively develop our sales, marketing and
  distribution capabilities
• our ability to effectively maintain existing
  collaboration partnerships and to establish new
  collaboration partnerships