GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Kamada and PARI Expand AAT Collaboration

[Kamada’s inhaled AAT (the subject of this PR) is in phase-2 for AAT HD, CF (#msg-25990907), and bronchiectasis (#msg-26698235), while Kamada’s injected AAT is in phase-3 for CF (#msg-23870707). Both Kamada programs rely on plasma-derived AAT. Please see #msg-25174719 and #msg-25848126 for musings on how GTC may eventually be able to break Kamada’s orphan designation for inhaled AAT by virtue of having a recombinant product.]

http://biz.yahoo.com/bw/080225/20080225005566.html

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Monday February 25, 3:04 am ET

The New Agreements Include a Long Term Supply Agreement as Well as the Exclusive License to Use PARI's eFlow® Electronic Drug Nebulizer With Additional Indications for Kamada's AAT Drug

NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada (TASE:KMDA), a bio-pharmaceutical company (www.kamada.com) engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, signed two new strategic development agreements with PARI Pharma, a world leader in inhalation solutions.

One of these agreements is for the conjoint clinical development of aerosolized AAT for treating the indications of Cystic Fibrosis (CF) and Bronchiectasis, in addition to Alpha-1 Antitrypsin Deficiency (AATD). Under the agreement PARI grants Kamada an exclusive license to use an optimized eFlow® Electronic Nebulizer to deliver AAT in its clinical trials also for these indications.

The other agreement is a long term agreement to supply the optimized eFlow® for the marketing, distribution, and commercialization of Kamada’s AAT, pending successful conclusion of the clinical trials.

According to David Tsur, CEO Kamada, "We are extremely pleased with the expansion of our collaboration with PARI, an important strategic partner. These agreements demonstrate a vote of confidence in Kamada. The next generation product, AAT for inhalation, holds numerous advantages over the currently used AAT for intravenous administration. Among these advantages are greater patient convenience, reduced treatment costs, larger treatment population and additional potential indications, all pending successful completion of the company's clinical development plan. Kamada's AAT for intravenous administration, soon to complete Phase III studies in the US and already marketed in several countries, also holds numerous advantages over competing products, including its liquid, ready to use formulation allowing easier drug handling and its exceptional purity level. These features of the intravenous AAT product, together with the exclusive rights for the use of the eFlow® inhalation device by PARI for AAT, formed the basis for the development of the aerosolized product by Kamada."

Mr. Tsur added that "There is continuously growing clinical evidence from all over the world indicating that the rationale in treating Congenital Emphysema with AAT is also valid for treating other respiratory diseases, such as CF and Bronchiectasis. Therefore, we are developing the product for these additional indications as well. While according to the US Alpha-1 organization the estimated number of AATD subjects worldwide is approximately 200,000, an independent survey indicates that only 5,000 of these patients are currently treated. We therefore see a significant prospective in the treatment of AATD with the aerosolized AAT drug. Additionally, the estimated number of CF subjects worldwide according to the US CF Foundation is 70,000 subjects while according to the COPD Foundation (representing Bronchiectasis patients) there are approximately 100,000 Bronchiectasis patients in the US alone."

Kamada recently announced that it has concluded Phase I clinical trials with aerosolized AAT [#msg-25990836]. Additionally, EMEA has already approved the company's clinical plan for Phase II-III studies with the product, thereby enabling the company to move forward with the development of its flagship product.

Kamada's aerosolized AAT drug was designated by both the US-FDA and the European Agency for the Evaluation of Medicinal Products (EMEA) as an Orphan Drug for two indications - Congenital Emphysema and CF. [However, GTC may eventually be able to break Kamada’s AAT orphan designation for inhaled AAT by virtue of having a recombinant product: #msg-25174719, #msg-25848126.] This important attribute has granted the company research funds benefits, waiver of user fees and free scientific advice by the regulatory authorities. Furthermore, if Kamada is the first company to successfully complete clinical trials and receive marketing approval in the US or the EU, the company shall gain exclusive marketing rights for the duration of seven years in the US, and for 10 or 12 years in Europe.

About PARI’s eFlow®

eFlow®, an electronic, portable nebulizer, enables extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane. Compared to other nebulizer systems, eFlow® can produce aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible amount of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, PARI’s eFlow® helps reduce the burden of taking daily inhaled treatments.

About PARI Pharma

PARI Pharma develops aerosol delivery devices and inhaled therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma specializes in treatments for pulmonary and nasal administration optimized to advanced delivery platforms, such as the eFlow®.

About Kamada

Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing and marketing a line of specialty life-saving therapeutics using its proprietary chromatographic purification technologies. Licensed and marketed in more than 15 countries, several of these specialty therapeutics hold registered and pending patents and are currently in advanced clinical trials.
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