Teva UK Limited, the UK's leading generics manufacturer, is entering a whole new market sector by launching an over the counter (OTC) range of medicines. 

Delivering "Good Health for less", the comprehensive range will initially feature high quality analgesic, gastro-intestinal, allergy and cold and flu relief products, with more than 20 lines in total (P1 and GSL2).
Ryan Ruscoe, OTC Brand Manager for Teva UK Limited, says: "We've selected the range to meet consumers' everyday healthcare needs, and to give them a real alternative to leading brand remedies." 

He adds: "This is a great opportunity for pharmacy to deliver superb value to their customer and achieve excellent returns on their bottom line through a quality range of good value products. We're delighted that Teva - the established name behind the counter - will soon be available over the counter." 

Kim Innes, Teva's Commercial Director, explains: "We're always looking at different ways to help our pharmacy customers. Our generics portfolio is already the widest of any other UK generics supplier, and branching out into OTCs seems like the next logical step. We believe that our OTC range will really add further value, helping them achieve their business goals in this challenging healthcare environment." 

A full consumer launch is scheduled for the autumn, and further products will also be launched in the new year. 

This press release was originally published by Teva UK; to read the press release in its original context, please follow the link: Teva

Bristol-Myers Squibb Company and ZymoGenetics, Inc. announced today that the companies have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $9.75 per share in cash. The transaction, with an aggregate purchase price of approximately $885 million, or approximately $735 million net of cash acquired, has been unanimously approved by the boards of directors of both companies. The board of directors of ZymoGenetics intends to recommend that ZymoGenetics' shareholders tender their shares in the tender offer. In addition, shareholders holding approximately 37% of the outstanding shares of ZymoGenetics' common stock have entered into agreements with Bristol-Myers Squibb to support the transaction and to tender their shares in the offer.

"The acquisition of ZymoGenetics brings us full ownership of a promising investigational biologic that strengthens our very diversified Hepatitis C portfolio. Building on our leadership in virology, we are developing a strong portfolio to help patients with Hepatitis C," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. "In addition, ZymoGenetics brings proven capabilities with therapeutic proteins and revenue from a marketed specialty surgical biologic. This acquisition is another example of our strategic, targeted approach to business development."

"By joining forces with Bristol-Myers Squibb, we believe we will enhance the long-term potential of ZymoGenetics' portfolio of assets, while providing a compelling valuation for our shareholders," said Douglas E. Williams, Ph.D., chief executive officer of ZymoGenetics. "Our collaboration with Bristol-Myers Squibb in the development of PEG-Interferon lambda has been extremely positive and it has given us an opportunity to fully appreciate their capabilities. We believe that this transaction will maximize the potential for our products and product candidates to make a meaningful difference for patients in need."

Bristol-Myers Squibb gains the following as a result of the acquisition:

• Full ownership of pegylated-interferon lambda, a novel interferon in Phase IIb development for the treatment of Hepatitis C infection, which, if approved, could be an important contributor to Bristol-Myers Squibb's future growth. The companies have collaborated on the development of pegylated-interferon lambda since January 2009. Four-week and 12-week results from a Phase IIa study will be presented at the American Association for the Study of Liver Diseases meeting later this year.
• RECOTHROM^®, a recombinant thrombin approved by the U.S. Food and Drug Administration for use as a topical hemostat to control non-arterial bleeding during surgical procedures.
• IL-21 protein, a cytokine currently being tested in an open-label, Phase II clinical study as a potential immunotherapy treatment for metastatic melanoma.
• An earlier-stage pipeline of six biologic drug candidates, including an anti-IL-31 antibody, currently in pre-clinical development for atopic dermatitis.
• Potential milestone and royalty payments from six partnered programs in various stages of clinical development by EMD Serono, Inc., an affiliate of Merck KGaA, and Novo Nordisk.

"ZymoGenetics is a leader in advancing novel biologics, particularly genomics-based therapies," said Elliott Sigal, M.D., Ph.D., executive vice president and chief scientific officer, Bristol-Myers Squibb. "We expect ZymoGenetics' pipeline and biologics capabilities to complement and enhance our existing efforts in Hepatitis C, oncology and immunoscience."

Initially, the transaction is expected to be modestly dilutive to earnings per share (EPS) for Bristol-Myers Squibb. In 2010, the transaction is expected to be dilutive to EPS by approximately $0.03. In 2011, the transaction is expected to be dilutive to EPS by approximately $0.07.

Under the terms of the definitive agreement, Bristol-Myers Squibb will commence a cash tender offer on or about September 9, 2010, to purchase all of the outstanding shares of ZymoGenetics' common stock for $9.75 per share. The closing of the tender offer is subject to customary terms and conditions, including the tender of a number of shares which is equal to or greater than 48,282,192 shares (which represents approximately 56% of the outstanding shares as of August 31, 2010, which represents a majority of the shares on a fully-diluted basis, excluding certain shares underlying derivative securities that are significantly out-of-the-money), and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The agreement also provides for the parties to effect, subject to customary conditions, a merger to be completed following the completion of the tender offer which would result in all shares not tendered in the tender offer being converted into the right to receive $9.75 per share in cash. The merger agreement contains a provision under which ZymoGenetics has agreed not to solicit any competing offers for the company. Bristol-Myers Squibb will finance the acquisition from its existing cash resources. The companies expect the tender offer to close approximately thirty days after commencement of the tender offer.

Morgan Stanley & Co. Incorporated is serving as financial advisor to Bristol-Myers Squibb in connection with the acquisition, and Bristol-Myers Squibb is represented by Kirkland & Ellis LLP. Goldman, Sachs & Co. is serving as financial advisor to ZymoGenetics in connection with the acquisition, and ZymoGenetics is represented by Latham & Watkins LLP and Fenwick & West LLP.

This press release was originally published by Bristol-Myers Squibb; to read the press release in its original context, please follow the link: Bristol-Myers Squibb

Shire plc , the global specialty biopharmaceutical company, today announced the commencement of the tender offer by its subsidiary Shire Holdings Luxembourg S.à.r.l. to acquire all outstanding shares and warrants of Movetis NV.  Shire announced on 3 August 2010 that it would launch a voluntary public takeover offer for all of the shares in Movetis. The board of directors of Movetis has issued a memorandum recommending that the security holders of Movetis accept Shire's tender offer.

The acceptance period for the tender offer opens on September 6, 2010 and is scheduled to close on September 27, 2010 at 4 p.m. (Central European Time).  The results of the tender offer will be published no later than October 4, 2010 and if the offer is successful, settlement will take place no later than October 18, 2010.  Shire has offered €19 in cash for each share, €2,67 EUR for each Warrant 2006, €2,67 EUR for each Warrant 2007, €2,61 EUR for each Warrant 2008 (1), €2,48 EUR for each Warrant 2008 (2) and €2,27 EUR for each Warrant 2009.

Shire has entered into agreements with institutional shareholders in which they have unconditionally committed 38.9% of Movetis' existing ordinary share capital to the offer.  Additionally, a shareholder controlling a further 5.9% of Movetis' existing ordinary share capital has entered into an agreement to tender its shares to the offer; this commitment will lapse if a counter-offer is made.

The prospectus relating to the tender offer and the Movetis board memorandum recommending that shareholders accept the offer were approved by the Belgian regulator, the Commission bancaire, financière et des assurances ("CBFA"), on August 30, 2010.  Additional details regarding the offer and related acceptance procedures are described in the prospectus related to the offer. 

This press release was originally published by Shire Pharmaceuticals; to read the press release in its original context, please follow the link: Shire

GlaxoSmithKline today issued the following statement in anticipation of the BBC Panorama programme, 'A risk worth taking?' which is scheduled to be aired this evening.

We are concerned that the BBC Panorama programme could alarm patients and their families about the use of Avandia (rosiglitazone) for the treatment of type 2 diabetes.  This is a chronic and serious disease that if left untreated can result in serious health problems.

Patients concerned by the programme should seek advice from their doctor and not stop their medication.

The company has not seen the programme but denies any suggestions that it has put patients at risk.  We consider patient safety a priority.

Avandia is currently under review by the European (EMA) and US (FDA) medicines regulatory authorities and GSK acknowledges the significant efforts these independent bodies have made to apply scientific rigour to understanding the benefit-risk profile of Avandia.

We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia.  No other diabetes medicine introduced in the last 10 years has such an extensive safety database.  The results from this research programme have been given to regulatory authorities worldwide.

Our view remains that controlled clinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines.

Taken together, the data from these types of trials have shown that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes medicines.  We continue to believe that Avandia is safe and effective when it is prescribed appropriately.

The company understands that the BBC Panorama programme will feature an audio recording of a meeting between GSK medical and clinical experts and Dr Steve Nissen. This meeting, which was hosted by Dr Nissen, took place on 10^th May 2007. Four GSK scientists met with Dr Nissen to discuss the scientific data onAvandia.

The audio recording of this meeting was made covertly by Dr Nissen. At no stage before or during the meeting was GSK informed that the meeting was being recorded. Selected extracts from this audio recording have already been provided by Dr Nissen to The New York Times newspaper.

In pre-publicity materials for the programme, BBC Panorama suggests that this recording is the "secret tape the drug company would rather you didn't hear."

On Friday 3 September 2010, following the issuing of a subpoena (legal request) to Dr Nissen, GSK obtained a copy of the audio recording.  The company today (6 September) posted the recording to its website www.gsk.com.

The company has taken this action so that all interested parties can hear all the comments made at this meeting in their full context.

For our part, we regret if any comments made by GSK during this meeting might be misinterpreted as seeking to stifle an independent view of the science aroundAvandia.

We have diligently shared our data relating to the cardiovascular safety of Avandiain a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website.

We remain fully committed to maintaining best practice disclosure of clinical data for all our medicines to serve the interests of patients, physicians and regulators.

This press release was originally published by GlaxoSmithKline; to read the press release in its original context, please follow the link: GSK

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada emtricitabine and tenofovir disoproxil (as fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 rilpivirine (as hydrochloride) for the treatment of HIV-1 infection in adults. Pending approval, the new single-tablet regimen would be only the second product that contains a complete antiretroviral treatment regimen in a single once-daily tablet.

The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP). Review of the MAA will be conducted by the EMA under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 27 member states of the European Union. An MAA for TMC278 also is being submitted today by Tibotec to the EMA for review.

"The important role of complete, fixed-dose HIV treatment regimens is well established in Europe," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "Today, nearly one quarter of HIV patients in the major European countries are taking a one pill, once-daily regimen, and recent updates to the International AIDS Society guidelines support the use of these simplified regimens. We are pleased to work with Tibotec in contributing another potentially important new once-daily, fixed-dose treatment option."

The regulatory application for the fixed-dose combination is supported by 48-week data from two Phase III double-blind, randomized studies (ECHO and THRIVE) evaluating the safety and efficacy of TMC278 in treatment-naive HIV-1 infected adults and a bioequivalence study conducted by Gilead, which demonstrated that the formulation of the fixed-dose combination of Truvada and TMC278 achieved the same levels of medication in the blood as the component products dosed simultaneously. ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and Efavirenz) evaluated TMC278 (25 mg) combined with a fixed-dose background regimen consisting of emtricitabine (200 mg) and tenofovir disoproxil fumarate (245 mg). THRIVE (TMC278 against HIV, in a once-daily RegImen Versus Efavirenz), evaluated once-daily TMC278 (25 mg) compared to once-daily efavirenz (600 mg) combined with an investigator-selected background regimen consisting of two nucleoside reverse transcriptase inhibitors (abacavir and lamivudine, or emtricitabine and tenofovir disoproxil fumarate, or zidovudine and lamivudine).

Gilead entered into a license and collaboration agreement with Tibotec Pharmaceuticals for the development and commercialization of a single-tablet regimen containing TMC278 and emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV in July 2009. In April 2010, Gilead announced that it had successfully formulated and obtained data supporting bioequivalence of the fixed-dose combination.

This press release was originally published by Gilead; to read the press release in its original context, please follow the link: Gilead

Genzyme  today confirmed that it has received an unsolicited, non-binding proposal from Sanofi-Aventis to acquire all the outstanding shares of Genzyme for $69 per share in cash. The Genzyme board of directors met last night, unanimously affirmed its previous rejection of Sanofi's proposal, and instructed the company to send Sanofi the following response letter:

The Genzyme board is now in receipt of your second unsolicited letter proposing to acquire the company for $69 per share in cash. This letter, received yesterday, is identical to last month's offer. It provides no new information and no improvement in price, and therefore fails to establish a basis for engagement by the Genzyme board.Dear Mr. Viehbacher:

This should come as no surprise to Sanofi. On August 11, 2010, Genzyme responded to your first letter dated July 29, 2010. In our response, we stated that, "without exception, each member of the Genzyme board believes this is not the right time to sell the company, because your opportunistic takeover proposal does not begin to recognize the significant progress underway to rectify our manufacturing challenges or the potential for our new-product pipeline." Our board met last evening in response to your second letter and unanimously confirmed those views.

As you are well aware, our bankers met with your financial advisors on August 24, 2010, and provided very useful, non-public information regarding progress the company has made to meaningfully improve its manufacturing capacity, the tremendous future upside of our multiple sclerosis drug alemtuzumab, and our outlook for significant cost reductions that will further drive our earnings growth. Moreover, last week's public announcement that we have begun to increase the supply of Cerezyme for patients with Gaucher disease to near-normal levels, and that supplies of Fabrazyme for patients with Fabry disease will increase beginning in the fourth quarter, further illustrates the progress we are making as well as the opportunistic nature of your proposal.

Notwithstanding this information and assistance, you have not increased your price above $69 per share. You and your advisors claim you are willing to pay more but that you are unwilling to "bid against yourself." The Genzyme board is not prepared to engage in merger negotiations with Sanofi based upon an opportunistic proposal with an unrealistic starting price that dramatically undervalues our company.

As you know, the Genzyme board includes representatives of some of our major shareholders. Our board has worked actively to understand the true value of our company and is unanimous and resolute in its commitment to maximize Genzyme's future value for all of our shareholders.

Yours truly,

Henri A. Termeer
Chairman and Chief Executive Officer

Genzyme noted that there is no need for company shareholders to take any action at this time. Genzyme's financial advisors are Credit Suisse Securities (USA) LLC and Goldman, Sachs & Co., and its legal advisor is Ropes & Gray LLP.

This press release was originally published by Genzyme; to read the press release in its original context, please follow the link: Genzyme

Results of a significant Phase III EINSTEINDVTstudy, presented at the European Society of Cardiology (ESC) today, confirmed that,for the first time since the introduction of warfarin 55 years ago,1 we have taken a steptowards being able to potentially offer an oral single-drug approach as an alternative totraditional standard treatment [a combination of low molecular weight heparin (LMWH)and warfarin] to patients with deep vein thombosis (DVT).2"Whilst the current treatment, which has been around for more than 50 years, is effective whenwell-controlled, it is important to manage its dosage and administration safely. If I could design aDVT treatment it would be oral, once-daily, have reduced drug and food interactions, and requireno blood test monitoring. The results from this study are promising as there is now the potentialfor a single-drug approach rather than the current treatment, which requires a combination of twodifferent therapies. This condition affects around 60,000 people in the UK each year, who couldpotentially benefit from this new development," says Professor Sam Machin, ConsultantHaematologist at University College London.In the study, patients with acute proximal symptomatic DVT received either oral rivaroxaban orLMWH enoxaparin followed by a vitamin K antagonist (VKA) of either warfarin or acenocoumarol,dose adjusted to maintain a therapeutic International Normalised Ratio (INR) (target 2.5, range2.0-3.0), for 3, 6 or 12 months.2TREATMENT OF DEEP VEIN THOMBOSISFirst single-drug approach anticoagulation therapy shown to beeffective in treatment of DVTUK.PH.GM.XAR.2010.187Date of preparation: August 2010- 2/5 -When compared to current standard treatment, Rivaroxaban demonstrated:2 Non-inferiority in terms of the primary efficacy outcome [defined as the cumulativeincidence of symptomatic recurrent DVT and non-fatal or fatal pulmonary embolism (PE)]:2.1% vs. 3.0% respectively (p <0.0001 for non-inferiority) A comparable safety profile [principal safety outcome defined as a composite of majorand non-major clinically relevant bleeding events]: 8.1% in both treatment groups,(p=0.77) A superior net clinical benefit [a pre-specified secondary outcome defined as thecomposite of the primary efficacy outcome plus major bleeding]: 2.9% vs. 4.2%respectively (HR of 0.67, CI: 0.47 - 0.95) No statistically significant difference in the other secondary outcomes:o all-cause mortality: 2.2% vs. 2.9% respectively (HR of 0.67, CI: 0.44 - 1.02)o cardiovascular events: 0.7% vs. 0.8% respectively (HR of 0.79, CI: 0.36 - 1.71)Rivaroxaban was well-tolerated in the study, and discontinuation rates related to adverse eventswere low and similar in both treatment groups.2EINSTEIN-DVT is the fifth Phase III trial in the ongoing rivaroxaban global developmentprogramme in which it demonstrated either non-inferiority (EINSTEIN-DVT) or superiority(RECORD 1-4) when compared to current anticoagulation therapies.Bayer's first regulatory filings in the VTE treatment setting are planned for the second half of 2010.Rivaroxaban is currently licensed for use in the UK for VTE prevention in adult patientsundergoing elective hip or knee replacement surgery. 

This press release was originally published by Bayer Schering Pharma; to read the press release in its original context, please follow the link: Bayer Plc

GlaxoSmithKline (GSK) confirmed that the European Commission has granted Marketing Authorisation to amend the licence for its cervical cancer vaccine,Cervarix®.

The approval from the European Commission is important as it recognises the extent of cervical cancer protection demonstrated by Cervarix®, which was not highlighted by the previous indication. The licence amendment is supported by data from the largest efficacy trial of a cervical cancer vaccine conducted to date, the PATRICIA study, and acknowledges that Cervarix® has shown efficacy beyond HPV 16 and 18, the two virus types contained in the vaccine.

The summary of product characteristics (SPC) for Cervarix® will be updated to include the prevention of precancerous lesions and cervical cancer causally related to certain strains of the human papillomavirus (HPV) and will reflect data showing efficacy against the two vaccine types contained in the vaccine (HPV 16 and 18) and the three next most common cancer-causing virus types (HPV 31, 33 and 45).* Together these five HPV types (16, 18, 31, 33 and 45) account for 80 percent of all cervical cancers.

This press release was originally published by GlaxoSmithKlein; to read the press release in its original context, please follow the link: GSK

The Alcon Independent Director Committee (the "IDC") notes the closing of Novartis AG's ("Novartis") acquisition of Nestlé SA's ("Nestlé") remaining stake in Alcon, Inc. ("Alcon"). The transaction, which increases Novartis' stake in Alcon to approximately 77 percent, was consummated pursuant to the Purchase and Option Agreement entered into by Nestlé and Novartis on April 6, 2008. The closing of the Nestlé/Novartis transaction is an expected step and does not impact the IDC's position with respect to Novartis' merger proposal to minority shareholders.

Thomas G. Plaskett, Chairman of the IDC, said, "We look forward to negotiating a deal that affords fair value to Alcon's minority shareholders. An agreed transaction is in the best interests of all stakeholders and is clearly preferable to protracted litigation, which would delay critical steps in the integration process. However, we are ready to defend the rights of Alcon and its minority shareholders if Novartis refuses to negotiate a fair deal."

The closing of the Nestlé/Novartis transaction satisfies the condition of the election of Novartis' five additional designees to Alcon's board, which was made on August 16^thdespite their overwhelming rejection by minority shareholders. The Novartis designees have a clear conflict of interest with respect to any decision regarding Novartis' merger proposal to minority shareholders. As previously announced by the IDC and supported in a legal opinion issued by Professor Hans Caspar von der Crone, a leading Swiss corporate governance expert, the role of non-conflicted directors in related-party transactions is established both by Swiss law and Alcon's organizational documents. Accordingly, a positive recommendation by the IDC is required with respect to any related-party transaction between Alcon and Novartis, including the merger proposal, and the IDC's powers and duties cannot be altered without the consent of the IDC.

This press release was originally published by Alcon Laboratories, Inc.; to read the press release in its original context, please follow the link: Alcon

 Inspire Pharmaceuticals announced today it has entered into an Amended and Restated License, Development and Marketing Agreement with Allergan, Inc., which revises terms related to the PROLACRIA(TM) (diquafosol tetrasodium ophthalmic solution) 2% development program and Inspire's right to receive revenues from Allergan based on net sales of RESTASIS^(R) (cyclosporine ophthalmic emulsion) 0.05% and any other human ophthalmic formulations of cyclosporine owned or controlled by Allergan.

"This agreement provides clarity on the revenue stream and respective responsibilities of the parties in our ophthalmic collaboration," said Adrian Adams, President and CEO of Inspire. "We have solidified the term for potential RESTASIS^(R) and follow-on product revenues and have eliminated any financial commitment for both the continued development of PROLACRIA(TM) and the co-promotion of RESTASIS^(R). We are pleased to have now gained sole control over any future PROLACRIA(TM) development while retaining the right to leverage the asset as appropriate. At this time, we are not planning to proceed with clinical development of PROLACRIA(TM). Our strategy is to create shareholder value by focusing resources on our AZASITE^(R) franchise and our potentially transformational denufosol tetrasodium for cystic fibrosis program."

Under the amended agreement, which now runs through December 31, 2020, Inspire is entitled to receive revenues at one global rate based on net sales of RESTASIS^(R) and any other human ophthalmic formulation of cyclosporine owned or controlled by Allergan, with no requirement to co-promote RESTASIS^(R). The royalty rate for RESTASIS^(R) in the United States remains unchanged for the remainder of 2010. The annual global rate steps down from the 2010 U.S. rate by three percentage points in 2011, a further 0.25 percentage point in 2013, and a final 0.50 percentage point in 2014, remaining at this level through the end of the term in 2020.

Under the amended agreement, Inspire now has unilateral control over any future PROLACRIA(TM) development and commercialization. In the event Inspire resumes the PROLACRIA(TM) clinical development program and receives regulatory approval for a PROLACRIA(TM) product in a particular country, it will have the option to offer PROLACRIA(TM) commercialization rights to Allergan for such country. If Inspire chooses not to offer Allergan PROLACRIA(TM) commercialization rights with respect to a country, Inspire will receive all the commercialization revenues related to PROLACRIA(TM) in such country and Inspire's rights to receive revenues from Allergan based on net sales of RESTASIS^(R) products in such country will terminate.

Under the prior agreement, RESTASIS^(R) royalties would have been reduced by thirty percent if the joint development committee elected to terminate the PROLACRIA(TM) development program and Inspire elected not to co-promote RESTASIS^(R). Under the prior agreement, Inspire was entitled to receive revenues based on net sales of RESTASIS^(R) and on any other human ophthalmic formulation of cyclosporine owned by Allergan on a country-by-country basis for a term equal to the later of (i) the applicable patent term covering such product in such country, and (ii) 10 years from commercial launch of such product.

About Inspire

Inspire is a biopharmaceutical company focused on researching, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire's goal is to build and commercialize a sustainable portfolio of innovative new products based on its technical, scientific and commercial expertise. Inspire's clinical pipeline includes denufosol tetrasodium for cystic fibrosis in Phase 3 development and AZASITE^(R)(azithromycin ophthalmic solution) 1% for blepharitis in Phase 2 development. Inspire receives revenues related to the promotion of AZASITE^(R) for bacterial conjunctivitis, the co-promotion of ELESTAT^(R) (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and royalties based on net sales of RESTASIS^(R) (cyclosporine ophthalmic emulsion) 0.05% for dry eye. For more information, visit www.inspirepharm.com.

Forward-Looking Statements

The forward-looking statements in this news release relating to management's expectations and beliefs are based on preliminary information and management assumptions. Specifically, no assurance can be made with respect to: future net sales of RESTASIS^(R); Allergan's development and commercialization of any other human ophthalmic formulation of cyclosporine, whether the Company will ever receive revenues based on net sales of any such products and, if so, the amount of any such revenues; the possible future clinical development and commercialization of PROLACRIA(TM) and any costs associated therewith; the Company's ability to create shareholder value by focusing resources on its AZASITE^(R) franchise and its potentially transformational denufosol tetrasodium for cystic fibrosis program; the length of time Allergan will commercialize RESTASIS^(R); the amount, timing or impact of any reduction in the Company's potential resource and financial commitment by eliminating the burden of co-promoting RESTASIS^(R); the potential for the Company to resume clinical development of the PROLACRIA(TM) program and the Company's ability to receive regulatory approval for a PROLACRIA(TM) product in any country even if development is resumed; if approval of a PROLACRIA(TM) product occurs, whether or not the Company will offer PROLACRIA(TM) commercialization rights with respect to a country and, if it does make such an offer, whether or not Allergan will exercise such rights and the Company's rights to PROLACRIA(TM) commercialization revenues in such country will terminate; or the Company's ability to build and commercialize a sustainable portfolio of innovative new products based on its technical, scientific and commercial expertise. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, the timing of a launch of a generic form of ELESTAT^(R), intellectual property rights, competitive products, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof.

This press release was originally published by Inspire Pharma; to read the press release in its original context, please follow the link: Inspire