PENWEST PHARMACEUTICALS CO.

PENWEST PHARMACEUTICALS CO.

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Company Overview
Penwest Pharmaceuticals Co. is a publicly quoted company engaged in the development of pharmaceutical products that address disorders of the nervous system. The company has its registered headquarters in Danbury, Connecticut, USA.
Penwest Pharmaceuticals’ products are used in the treatment of pain, epilepsy, Parkinson’s disease and spasticity, as well as edema resulting from congestive heart failure. Its brand names are Opana ER, Procardia XL, Slofedipine XL, Cronodipin, and Cystrin CR. The company’s drug delivery technologies include TIMERxr, an oral controlled release delivery system that modifies the release of drugs, thus, providing therapeutic benefit to patients; Geminexr, a dual drug delivery system that independently releases combined active ingredients; and SyncroDose, a technology that provides a variety of preset lag times that can control when and where a drug is released.
Penwest Pharmaceuticals’ products are marketed to such countries as the United States, the United Kingdom, Italy, Brazil, and Finland.
The company’s common shares are traded on the NASDAQ (National Association of Securities Dealers Automated Quotations) under the symbol “PPCO”.
Business Summary
Penwest Pharmaceuticals Co. is a drug development company focused on identifying and developing products, which addresses unmet medical needs, primarily for rare disorders of the nervous system. The Company is developing A0001, or a-tocopherolquinone, a coenzyme Q analog, for inherited mitochondrial respiratory chain diseases. It is also applying the drug delivery technologies and drug formulation knowledge to the formulation of product candidates under licensing collaborations.
Description and history
Penwest Pharmaceuticals Co. is a drug development company focused on identifying and developing products, which addresses unmet medical needs, primarily for rare disorders of the nervous system. The Company is developing A0001, or a-tocopherolquinone, a coenzyme Q analog, for inherited mitochondrial respiratory chain diseases. It is also applying the drug delivery technologies and drug formulation knowledge to the formulation of product candidates under licensing collaborations.

Opana ER is an extended release formulation of oxymorphone hydrochloride developed with Endo Pharmaceuticals Inc. (Endo) using the TIMERx drug delivery technology. In June 2009, Endo signed an agreement with Valeant Pharmaceuticals International (Valent) to develop and commercialize Opana ER in Canada, Australia and New Zealand. The Company is conducting two Phase IIa clinical trials of A0001. It initiated the one trial in patients with Friedreich’s Ataxia (FA), a rare degenerative neuro-muscular disorder, and the second trial in patients with the A3243G mitochondrial deoxyribonucleic acid (DNA) point mutation associated with MELAS syndrome, a rare progressive neurodegenerative disorder. The Company has developed the Nifedipine XL, a generic version of Procardia XL based on the TIMERx technology under a collaboration agreement with Mylan Pharmaceuticals Inc. (Mylan).

TIMERx

The TIMERx drug delivery platform is based on a hydrophilic matrix combining a heterodispersed mixture composed primarily of two polysaccharides, xanthan gum and locust bean gum, in the presence of dextrose. Under the TIMERx drug delivery system, drug release is controlled by the rate of water penetration from the gastrointestinal (GI), tract into the TIMERx gum matrix, which expands to form a gel and subsequently releases the active drug substance. The Company can control the release of the active drug substance in a tablet using the TIMERx technology by varying the proportion of the gums, together with the tablet coating and the tablet manufacturing process. Drugs using the TIMERx technology are formulated by combining the active drug substance, the TIMERx matrix and additional excipients, and compressing the mixture into a tablet.

Geminex

The Geminex dual release technology provides the independent release of one or more active ingredients in a single bi-layer tablet. The release of the active ingredients can be achieved at different rates involving two different controlled release profiles, or a controlled release and an immediate release profile. The technology is based on a bi-layer tablet, which utilizes TIMERx matrix in the controlled release layer or layers.

SyncroDose

The SyncroDose drug delivery system delivers the active drug substance within a specific site in the GI tract or at the optimal time after ingestion, which is referred to as chronotherapeutic delivery. SyncroDose is a technology based on the underlying TIMERx technology. The SyncroDose technology utilizes the TIMERx gum matrix in the coating of the tablet.

GastroDose

The gastroretentive drug delivery system provides controlled delivery of drugs in the upper GI tract. Drugs delivered orally are absorbed in the stomach and the upper portions of the GI tract.

The Company competes with IMPAX Laboratories Inc., Actavis South Atlantic LLC, Sandoz, Barr, Roxane, Watson, Santhera and Repligen Corporation.

Business Line
Engaged in the development of pharmaceutical products that address disorders of the nervous system
Subsidiary

Advisor
ERNST & YOUNG LLP
IPO date
8/31/1998
US SIC Code
2834
Company Address
Suite 11
39, Old Ridgebury Road
City province or state postal code
06810, DANBURY, CT
Phone: +1 203 796 3700
Fax: +1 203 794 1393
Country address: UNITED STATES OF AMERICA
Website url: www.penwest.com

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