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CEO Sets Sights on Building Shareholder Value at Theratechnologies: Getting Lead Drug to Market Top Priority.


MONTREAL -- Theratechnologies (TSX TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
:TH) today announced strategic initiatives aimed at maximizing shareholder value.The strategy and related business plan were developed over the past few months and approved by the Board of Directors yesterday.
Key elements include:

- Getting TH9507 on the market is top priority - more than $17
  million is earmarked for the HIV-associated lipodystrophy program
  in 2006.
- Strict value-creation criteria have been set for future development
  projects. Company focus will be on developing products like TH9507
  where commercial rights can be retained.
- THG213.29 in acute renal failure, TH9507 in cystic fibrosis and
  TH9507 in adult growth hormone deficiency are projects that meet
  the value-creation criteria.  All three will be advanced in 2006 as
  possible clinical projects for 2007.
- Type 2 diabetes and obesity are programs that do not meet our
  criteria and have been designated as out licensing candidates.
- Total burn rate for 2006 estimated at between $22 million and $25
  million, up from approximately $18 million in 2005.



In presenting the new business plan, President and Chief Executive Officer Yves Rosconi said, "Earlier in the year, we initiated a review of our diabetes strategy and we also undertook to identify follow-on indications for our lead compound, TH9507.These questions were subsequently rolled into a four-month, comprehensive strategic review by management, with advice from experts in the U.S. biotech bi·o·tech  
n. Informal
Biotechnology.


biotech
Noun

short for biotechnology

Noun 1.
 industry.The principal objective of the review was to identify strategies aimed at building value for our shareholders in the near term and over the longer term as well," Mr. Rosconi explained.

TH9507 in HIV-associated lipodystrophy lipodystrophy /lipo·dys·tro·phy/ (-dis´tro-fe) any disturbance of fat metabolism.

congenital generalized lipodystrophy , congenital progressive lipodystrophy total l.
 is key value-driver

"The key value driver in the short term is our Phase 3 program currently underway," Mr. Rosconi continued."The real success stories in our industry have been the companies that were able to bring products to market, and we believe we have an opportunity to achieve this with TH9507 in HIV-associated lipodystrophy. We have solid finances with approximately $40 million to finance our activities over the next couple of years; we own the intellectual property related to TH9507 and have retained its commercial rights. Our market research also tells us that HIV-associated lipodystrophy could be a very profitable indication for us.We are investing over $17 million in the lipodystrophy program in 2006 and the first Phase 3 results should be available in the fourth quarter.We are committed to keeping this program on track."

Strict criteria to build value

"Looking to the longer term, our goal is to build out from our R&D base to become a fully integrated biopharmaceutical company.By that we mean a business that integrates the full value chain -- a business capable of bringing a product from discovery all the way through to commercialization. This means we have to choose our projects carefully and we have adopted a set of value-creation criteria to guide us," Mr. Rosconi explained.
In order to be considered for future development by
Theratechnologies, drug candidates must:

- Have a competitive edge over products currently marketed or in
  development;
- Have a regulatory path and a manageable clinical program;
- Be aimed at a specialty market where commercial rights can be
  retained; and
- Have the potential for attractive profit margins and a rapid
  payback on investment.



New priorities and projects in product development

The new business plan will mean changes to Theratechnologies' product portfolio.

"When we applied these criteria to our pipeline of products, it was clear that a drug candidate we refer to as THG THG Tom's Hardware Guide
THG Tetrahydrogestrinone
THG Third Harmonic Generation (laser physics)
THG The Humble Guys (hacker group)
THG The Holmes Group
213.29 in acute renal failure acute renal failure Acute kidney failure Nephrology An abrupt decline in renal function, triggered by various processes–eg, sepsis, shock, trauma, kidney stones, drug toxicity-aspirin, lithium, substances of abuse, toxins, iodinated radiocontrast.  (ARF) is a project that warrants consideration as a clinical program," Mr. Rosconi stated."This project is a product of our ExoPep technology and is currently in preclinical studies preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
.There is no approved therapy for ARF, which often leads to severe complications such as long-term Long-term

Three or more years. In the context of accounting, more than 1 year.


long-term

1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term.
 dialysis dialysis (dīăl`ĭsĭs), in chemistry, transfer of solute (dissolved solids) across a semipermeable membrane. Strictly speaking, dialysis refers only to the transfer of the solute; transfer of the solvent is called osmosis.  or death.More than 100,000 cases of acute renal failure are reported in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  every year."

"In addition, we have known for some time that TH9507 has the potential to treat a number of different diseases.By applying the same value-creation criteria, we have now identified cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males.   and adult growth hormone deficiency growth hormone deficiency Hypopituitarism Endocrinology A condition which affects 1:4000 children; ♂:♀, 3-4:1 Etiology 70% of GHD is idiopathic and attributed to a prenatal insult, possibly due to hypothalamic dysfunction, given that GHD children  as other potential areas for development of TH9507.

"On the other hand, and despite some very promising and innovative projects, we concluded that our type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
 and obesity obesity, condition resulting from excessive storage of fat in the body. Obesity has been defined as a weight more than 20% above what is considered normal according to standard age, height, and weight tables, or by a complex formula known as the body mass index.  programs should not be pursued.These have been designated out licensing candidates and the funding previously allocated in this area has been reallocated to the priorities I have outlined today. This has also led to some adjustments to our staffing levels in the Company," Mr. Rosconi said.

TH9507 targets unmet un·met  
adj.
Not satisfied or fulfilled: unmet demands. 
 medical need

Theratechnologies' primary goal is to bring its lead product, TH9507, rapidly to market.The Company is currently enrolling patients for the first of two Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study.  testing TH9507 in HIV-associated lipodystrophy, with efficacy results expected in the fourth quarter of 2006

Commercial rights to be retained

HIV-associated lipodystrophy patients are treated by a relatively small number of specialist physicians, thus making it feasible for Theratechnologies to retain the commercial rights to TH9507 and potentially bring the product to market. This strategy is expected to capture more value from product sales and could result in a more rapid payback Payback

The length of time it takes to recover the initial cost of a project, without regard to the time value of money.
 of investment for shareholders. Theratechnologies' growth strategy and new business plan are based on developing and commercializing a series of products that share the same value-creating characteristics as TH9507 in HIV-associated lipodystrophy.

2005 targets met - 2006 a pivotal year

"We met all of our 2005 milestones in the first Phase 3 HIV-associated lipodystrophy study and we're on course to complete the enrolment in the first quarter of 2006," Mr. Rosconi stated. "This project is the cornerstone cornerstone

Ceremonial building block, dated or otherwise inscribed, usually placed in an outer wall of a building to commemorate its dedication. Often the stone is hollowed out to contain newspapers, photographs, or other documents reflecting current customs, with a view to
 of our efforts to build value for shareholders in the short term and 2006 will be a pivotal year with the Phase 3 results coming out in the fourth quarter," he continued.

"Looking further down the road, the Board of Directors and management have developed a very clear vision of the kind of company we want Theratechnologies to become.We have set ourselves the goal of building a business capable of bringing a product from discovery all the way through to commercialization; and today we are launching a plan to take us there", Mr. Rosconi concluded.

December 16th conference call and webcast

Theratechnologies will be hosting a conference call and a webcast tomorrow, Friday, December 16, 2005 at 8:00 a.m. eastern time. The subject of this conference call and webcast will be strategic initiatives and priorities that will have an impact on the Company's product portfolio.

You can access the webcast at the following links: www.vcall.com/IC/CEPage.asp?ID=99024 and http://www.theratech.com/. The webcast will be posted for 90 days.

For the conference call, interested participants are asked to dial the following numbers: 1-416-644-3430 or 1-800-814-4890. A replay of the conference call will be available as of December 16, 2005 at 10:30 a.m. until December 23, 2005 at 11:59 p.m. at the following number: 1-416-640-1917, code 21168274# or 1-877-289-8525, code 21168274#. Please call 5 minutes prior to the conference in order to ensure your participation.

About Theratechnologies

Theratechnologies (TSX:TH) is a Canadian biopharmaceutical company that discovers or acquires innovative drug candidates in order to develop them and bring them to market.The Company targets unmet medical needs in financially attractive specialty markets where it can retain full or partial commercial rights for its products. Its most advanced program is TH9507, now in Phase 3 clinical trials for a serious metabolic syndrome metabolic syndrome
n.
See syndrome X.


Metabolic syndrome
A group of risk factors for heart disease, diabetes, and stroke.
 known as HIV-associated lipodystrophy.The Company also has other promising projects at earlier stages of development.

Additional information about Theratechnologies

Further information relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 Theratechnologies is available on the Company's website at http://www.theratech.com/. The Company is listed on the Toronto Stock Exchange Toronto Stock Exchange (TSE)

Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options.
 under the symbol TH. Additional information, including the Company's Annual Information Form, is available on SEDAR SEDAR System for Electronic Document Analysis and Retrieval
SEDAR Southeast Data, Assessment, and Review
 at www.sedar.com.

This press release contains forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 regarding the future orientations of the Company and its financial position, the creation of value for the shareholders, and the clinical development of TH9507 and THG213.29 and their future commercialization in the indications described above. Such statements inherently involve numerous risks and uncertainties, including the availability of funds and resources, the success and timely completion of clinical trials and the granting of the necessary authorizations. Actual future results may differ materially from the anticipated results. Investors are cautioned against placing undue importance on forward-looking information contained herein and should consult the Company's 2004 Annual Report, which contains a more exhaustive analysis of risks and uncertainties connected to the businesses of the Company.

Theratechnologies inc. (TSX:TH)
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
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Date:Dec 15, 2005
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