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PharmaForm Announces Successful FDA Inspection
AUSTIN, TX (May 26, 2005) – PharmaForm, LLC, a specialty pharmaceutical company that provides contract R&D, manufacturing and analytical services to the pharmaceutical industry, today announced that it was recently inspected by the Food and Drug Administration. The inspection was successfully concluded without the issuance of a Form 483 deficiency.
As a pharmaceutical contract service provider, PharmaForm, LLC is continually expanding the scope of the contract services we provide to meet the growing needs of our valued client partners. This inspection was the result of a supplemental NDA that was filed in preparation for the contract manufacture of an NDA product. The successful execution of this inspection now allows PharmaForm to offer the full spectrum of pharmaceutical contract services from development to full commercial toll manufacturing and analytical testing.
About PharmaForm:
PharmaForm, a wholly owned subsidiary of Akela Pharma Inc., is a leading specialty contract service provider in the area of pharmaceutical dosage form development and manufacturing, specializing in controlled release and bioavailability enhancement technologies, such as hot melt extrusion, liquid filled capsules, solvent-based fluid bed processing and spray drying. Through its diverse offerings, PharmaForm solutions help pharmaceutical and biotechnology clients reach their development targets, reduce development costs and accelerate time-to-market.
About Akela Pharma Inc.:
Akela Pharma is a drug development company with its lead product, Fentanyl TAIFUN®, being developed for the treatment of breakthrough cancer pain. Fentanyl TAIFUN is a fast-acting fentanyl formulation delivered using the company’s TAIFUN multi-dose dry powder inhaler platform. Akela’s pipeline also includes a growth hormone releasing hormone (GHRH), which is being developed for frailty and wasting in chronic renal disease.
Akela’s common shares trade on The Toronto Stock Exchange (“TSX”) under the symbol “AKL” with 30.9 million shares outstanding.
This press release contains statements which may constitute forward-looking information under applicable Canadian securities legislation or forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1955. Such forward-looking statements or information may include financial and other projections as well as statements regarding the company’s future plans, objectives, performance, revenues, growth, profits, operating expenses or the company’s underlying assumptions. The words “may”, “would”, “could”, “will”, “likely”, “expect”, anticipate”, “intend”, “plan”, “forecast”, “project”, “estimate” and “believe” or other similar words and phrases may identify forward-looking statements or information. Persons reading this press release are cautioned that such statements or information are only expectations, and that the company’s actual future results or performance may be materially different.
Forward-looking statements or information in this press release include, but are not limited to, statements or information concerning our ongoing drug development programs and collaborations as well as the possible receipt of future payments upon achievement of milestones.
Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments to be materially different from results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, the possibility that risks associated with requirements for approvals by government agencies such as the FDA before products can be tested in clinical trials; the possibility that such government agency approvals will not be obtained in a timely manner or at all or will be conditioned in a manner that would impair our ability to advance development; risks associated with the requirement that a drug candidate be found safe and effective after extensive clinical trials; our dependence on suppliers, collaborative partners and other third parties and the prospects and timing for negotiating supply agreements, corporate collaborations or licensing arrangements; our ability to attract and retain key personnel; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at http:www.sedar.com.
Assumptions underlying our expectations regarding forward-looking statements or information contained in this press release include, among others, that future clinical trial results will be favorable; that our drug candidate will treat target diseases as intended; that we will raise enough capital, on reasonable terms and in a timely manner; that we will retain our key personnel; that we will obtain the necessary regulatory approvals.
In the event that any of these assumptions prove to be incorrect, or in the event that we are impacted by any of the risks identified above, we may not be able to continue in our business as planned.
For a complete discussion of the assumptions, risks and uncertainties related to our business, you are encouraged to review our filings with Canadian securities regulatory authorities, filed on SEDAR at http://www.sedar.com.
All forward-looking statements and information made herein are based on our current expectations as of the date hereof and we disclaim any intention or obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
For further information please contact:
PharmaForm
Elizabeth Hickman
Sales & Marketing Manager
Tel: 512-531-6644
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