Forma Therapeutics Announces $200 mn Collaboration Deal with Novartis
Filed under: Americas, Biotech, Capital Markets, Europe, Finance, JVs, M&A, Pharma
CAMBRIDGE, Mass. Jan 12, 2009 — FORMA Therapeutics announced today that it has entered into a license and option agreement through the Novartis Option Fund. Under the terms of the agreement, FORMA will leverage its transformative biology and chemistry platform to develop inhibitors for an undisclosed protein-protein interaction target in the field of oncology. The agreement includes an upfront fee and potential milestones totaling over $200 million as well as royalties.
“Protein-protein interactions represent important target opportunities in the field of oncology drug discovery, but have been highly elusive to date,” stated Reinhard Ambros, Head of the Novartis Venture Funds. “Novartis is very excited to be collaborating with FORMA to access their biology and chemistry expertise and powerful discovery tools to unlock this challenging target class.” Read more
Ranbaxy Sells Out Promoter Stake To Daiichi – Creates Generic Pharma Gaint
June 11, 2008, New Delhi and Tokyo:
Ranbaxy Laboratories Limited (NSE/BSE: Ranbaxy/500359) (“Ranbaxy”), among the top 10 generic companies in the world and India’s largest pharmaceutical company, and Daiichi Sankyo Company, Limited (TSE: 4568.JP) (“Daiichi Sankyo”), one of the largest pharmaceutical companies in Japan, today announced that a binding Share Purchase and Share Subscription Agreement (the “SPSSA”) was entered into between Daiichi Sankyo, Ranbaxy and the Singh family, the largest and controlling shareholders of Ranbaxy (the “Sellers”), pursuant to which Daiichi Sankyo will acquire the entire shareholding of the Sellers in Ranbaxy and further seek to acquire the majority of the voting capital of Ranbaxy at a price of Rs737 per share with the total transaction value expected to be between US$3.4 to US$4.6 billion (currency exchange rate: US$1=Rs43). On the post closing basis, the transaction would value Ranbaxy at US$8.5 billion.
Mr. Malvinder Singh will continue to lead the company as its CEO and Managing Director while additionally assuming the position of Chairman of the Board, upon closure.
Daiichi Sankyo and Ranbaxy believe this transaction will create significant long-term value for all stakeholders through:
A complementary business combination that provides sustainable growth by diversification that spans the full spectrum of the pharmaceutical business;
An expanded global reach that enables leading market positions in both mature and emerging markets with proprietary and non-proprietary products;
Strong growth potential by effectively managing opportunities across the full pharmaceutical life-cycle; and
Cost competitiveness by optimizing usage of R&D and manufacturing facilities of both companies, especially in India
Mr. Malvinder Mohan Singh, CEO and Managing Directorof Ranbaxy Laboratories Limited, said “I am delighted to announce our association with Daiichi Sankyo, a leading research based pharmaceutical company that puts us on a new and much stronger platform to harness our capabilities in drug development, manufacturing and global reach. Together with our pool of scientific, technical and managerial resources & talent, we would enter a new orbit to chart a higher trajectory of sustainable growth in the medium and long term in the developed and emerging markets organically and inorganically. This is a significant milestone in our Mission of becoming a Research based International Pharmaceutical Company.
“The proposed transaction is in line with our goal to be a Global Pharma Innovator and provides the opportunity to complement our strong presence in innovation with a new, strong presence in the fast growing business of non-proprietary pharmaceuticals” said Takashi Shoda, President & CEO of Daiichi Sankyo Company, Limited.”This complementary combination represents a perfect strategic fit and delivers a considerable opportunity for the future growth of the new Daiichi Sankyo Group. While both companies will closely cooperate to explore how to fully optimize our growth opportunities, we will respect Ranbaxy’s autonomy as a standalone company as well. We respect and believe in the management skill of Mr. Malvinder Mohan Singh and we are happy that we can invite him to be a member of the “Senior Global Management” of Daiichi Sankyo, while he continues to lead Ranbaxy as its CEO and Managing Director; additionally, upon closing he would assume the position of Chairman of the Board.”
The SPSSA has been unanimously approved by the Boards of Directors of both companies. Daiichi Sankyo is expected to acquire the majority equity stake in Ranbaxy by a combination of (i) purchase of shares held by the Sellers, (ii) preferential allotment of equity shares, (iii) an open offer to the public shareholders for 20% of Ranbaxy’s shares, as per Indian regulations, and (iv) Daiichi Sankyo’s exercise of a portion or all of the share warrants to be issued on a preferential basis. All the shares/warrants will be acquired/issued at a price of Rs737 per share.
This purchase price represents a premium of 53.5% to Ranbaxy’s average daily closing price on the National Stock Exchange for the three months ending on June 10, 2008 and 31.4% to such closing price on June 10, 2008.
The closing of the transactions is subject to approval of shareholders of Ranbaxy and customary regulatory and statutory approvals. The acquisition is expected to be completed by the end of March, 2009. Upon completion of the transaction, Ranbaxy is expected to become a subsidiary of Daiichi Sankyo.
The deal will be financed through a mix of bank debt facilities and existing cash resources of Daiichi Sankyo.
It is anticipated that the transaction will be accretive to Daiichi Sankyo’s EPS and Operating income before amortization of goodwill in the fiscal year ending March 31, 2010 (FY2009). EPS and Operating income after amortization of goodwill are expected to see an accretive effect in FY2010 and FY2009, respectively.
Nomura Securities Co., Ltd., the Japan headquartered investment bank, acted as the exclusive financial advisor, Jones Day as the legal advisor outside India, P&A Law office as the legal advisor in India, Mehta Partners LLC as the strategic business advisor and Ernst & Young as the accounting and tax advisor to Daiichi Sankyo.
Religare Capital Markets Limited, a wholly owned subsidiary of Religare Enterprises Limited, is the exclusive financial advisor to Ranbaxy and the Singh family. Vaish Associates are the legal advisors to Ranbaxy and the Singh family.
Joint Press Conference
Daiichi Sankyo and Ranbaxy will host a joint press conference to discuss the transaction as follows:
On June 11 at 1:30 pm in New Delhi (JST 5:00 pm)
On June 12 at 3:00 pm in Tokyo (IST 11:30 am)
About Daiichi Sankyo Company, Limited
Daiichi Sankyo Company, Limited, established in 2005 after the merger of two leading century-old Japanese pharmaceutical companies, is continuously generating innovative drugs that enrich the quality of life for patients around the world. The company uses its cumulative knowledge and expertise in the fields of cardiovascular disease, cancer, metabolic disorders, and infection as a foundation for developing an abundant product line-up and R&D pipeline. For more information, visit www.daiichisankyo.com
About Ranbaxy Laboratories Limited
Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies,” resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
Disclaimer
Statements contained in this press release regarding the benefits of the acquisition, the business outlook, the demand for the products and services, and all other statements in this release other than recitation of historical facts are forward-looking statements. Words such as “expect”, “estimate”, “project”, “budget”, “forecast”, “anticipate”, “intend”, “plan”, “may”, “will”, “could”, “should”, “believes”, “predicts”, “potential”, “continue”, and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, forecasts of market growth, future revenues, benefits of the proposed acquisition, expectations that the acquisition will be accretive to the results, future expectations concerning growth of business, cost competitiveness and expansion of global reach following the acquisition, and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: difficulties encountered in integrating businesses; uncertainties as to the timing of the acquisition; approval of the preferential allotment/transaction by the shareholders of Ranbaxy; the satisfaction of the closing conditions to the transaction, including the receipt of regulatory approvals; whether certain market segments grow as anticipated; the competitive environment in the pharmaceutical industry and competitive responses to the proposed acquisition; and whether the companies can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release.
This document does not constitute an offer to purchase or to sell securities in any jurisdiction.
Nabi Biopharmaceuticals Initiates New Strategic Alternatives Process
ROCKVILLE, Md., Jan. 22, 2008 — Nabi Biopharmaceuticals announced today that its Board of Directors has authorized the exploration of the full range of strategic alternatives available to the company in order to further enhance shareholder value. This strategic alternatives process will focus on, but is not limited to, a sale or merger of the company. Nabi has engaged Banc of America Securities LLC as financial advisor for this strategic process.
“The primary goal of this strategic alternatives process is to maximize shareholder value and we feel Nabi is now streamlined and well-positioned to do so,” said Dr. Raafat Fahim, newly-named President and Chief Executive Officer of Nabi. “With the sale of our Biologics business unit, Nabi has a very strong financial position, a focused pipeline of vaccine programs and a right-sized and lean organization. We believe that this strategic alternatives process can more fully optimize the value of our most promising assets, namely NicVAX(r) (Nicotine Conjugate Vaccine) and StaphVAX(r) (Staphylococcus aureus Vaccine).”
The successful outcome of this strategic alternatives process is the key corporate goal for this year. While advancing toward this goal, Nabi is also working to achieve several clinical milestones in 2008:
* Initiating a Phase 2 immunogenicity study for NicVAX(r) in 1H08
* Initiating a Phase 3 safety and efficacy trial for NicVAX(r) in 2H08
* Advancing the development of the new antigens of Nabi’s pentavalent
StaphVAX program, enabling the initiation of Phase 1 clinical trials
in early 2009
Following the successful sale of its Biologics Strategic Business Unit in December 2007, Nabi has re-emerged with a strong balance sheet, a significant potential PhosLo milestone and royalty stream, and a focused vaccine pipeline. The company is moving forward with compelling Phase 2 proof of concept clinical data from its NicVAX program and an expert core vaccine team. Dr. Raafat Fahim, President and CEO of Nabi, will discuss this strategic alternatives process, the company’s 2008 goals and its plan to achieve them on a conference call. More information about this call is outlined below.
Upon completion of this strategic alternatives process, Nabi will inform shareholders of the results. The company does not intend to disclose developments with respect to the exploration of strategic alternatives unless and until its Board of Directors has made a decision regarding a specific transaction and a definitive agreement has been executed.
Conference Call Information
The company will host a live webcast at 8:30 a.m. EST tomorrow, January 23, 2008.
The live webcast can be accessed at: http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=100445&eventID=1746962 (Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your browser. Remove the space if one exists.) or via the Nabi Biopharmaceuticals website at http://www.nabi.com.
If you do not have Internet access, the U.S./Canada call-in number is 800-638-5495 and the international call-in number is 617-614-3946. The participant passcode is 21708197. An audio replay will be available for U.S./Canada callers at 888-286-8010 and for international callers at 617-801-6888. The replay passcode is 58454245. An archived version of the webcast will also be available on the Company’s website, http://www.nabi.com. The press release is available on the company’s website at http://www.nabi.com.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of gram-positive bacterial infections and nicotine addiction. Nabi Biopharmaceuticals is currently developing NicVAX(r) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse, and StaphVAX(r) (Staphylococcus aureus Polysaccharide Conjugate Vaccine), a vaccine designed to prevent the most dangerous and prevalent strains of S. aureus bacterial infections. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit our Web site:http://www.nabi.com.
Forward-Looking Statements
Statements in this release that are not strictly historical are forward-looking statements including statements about the strategic alternatives process, clinical trials and studies, and potential PhosLo milestones and royalties. You can identify these forward-looking statements because they involve our expectations, beliefs, projections, anticipations or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to: successfully pursue strategic and other alternatives; obtain successful clinical trial results; receive PhosLo milestone and royalty proceeds; successfully partner with third parties to fund, develop, and manufacture our pipeline products, including NicVAX and our gram-positive infections products; realize anticipated cost saving; attract and maintain the human and financial resources to bring to market products in development; depend upon third parties to manufacture our products; achieve approval and market acceptance of our products; enter into and maintain arrangements with third parties to market and sell our products; comply with reporting and payment obligations under government rebate and pricing programs; raise additional capital on acceptable terms, or at all; and re-pay our outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and our Quarterly Report on Form 10-Q for the quarter ended September 29, 2007 filed with the Securities and Exchange Commission.
Biogen Idec completes Review of Strategic Alternatives
BIOGEN IDEC COMPLETES REVIEW OF STRATEGIC ALTERNATIVES
Company to Remain Independent
Cambridge, MA, December 12, 2007 – The Board of Directors of Biogen today announced that, after completing a review of strategic alternatives to maximize shareholder value, Biogen Idec will continue on its present course as an independent Company.
On October 12, the Board announced the start of a process to determine whether potential strategic interest on the part of major pharmaceutical companies might result in superior value for stockholders in the current environment. Biogen Idec, which was represented by independent financial advisors Goldman Sachs & Co. and Merrill Lynch & Co., conducted a comprehensive and thorough sale process. At the conclusion of this process, Biogen Idec did not receive any definitive offers to purchase the Company.
The Board emphasized that Biogen Idec’s business strategy is working and generating strong operating and financial performance. The Board noted that it is confident that continued execution of the Company’s business plan will result in attractive value for stockholders. As previously announced, Biogen Idec’s business plan is focused on achieving a series of goals by year-end 2010:
- 100,000 patients on TYSABRI® (natalizumab);
- More than 40% of the Company’s revenue coming from its International business;
- Four new products and/or existing products launched in new indications;
- Six programs in late-stage clinical development; and,
- Generating revenue growth at a 15% compound annual growth rate (CAGR) and non-GAAP EPS at a 20% CAGR from 2007 through 2010.
The Company reiterated guidance for the full-year 2007, which was first announced on July 24, in reporting its second-quarter financial results.
GAAP EPS Reconciliation for 2010 Goals
On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), the Company aims to grow GAAP EPS from 2007 through 2010 at a 25% CAGR. The long-term non-GAAP EPS goal excludes the impact of purchase accounting, merger-related adjustments, stock option expense, and their related tax effects. In order to reconcile long-term GAAP and non-GAAP EPS figures, the Company has excluded the following items for the years 2008 through 2010 from our non-GAAP EPS goal provided above:
- Purchase accounting charges, including amortization of acquired intangible assets and IPR&D, estimated to be $800-$840 million for already completed transactions;
- Stock option expense due to FAS 123R is estimated to be in the range of $80-$90 million;
- Tax benefit of $220-$240 million related to the pre-tax reconciling items.
Because the Company cannot predict with certainty the nature or the amount of non-operating or unusual charges through 2010, it has made no assumption regarding new purchase accounting charges in this GAAP EPS goal. The Company may incur charges or realize income through 2010 that could cause actual results to vary from the goal.
Use of Non-GAAP Financial Measures
Our “non-GAAP EPS” financial measure is defined as reported, or GAAP, EPS excluding, for the reasons discussed below, (1) purchase accounting and merger-related adjustments and (2) stock option expense. We believe it is important to share these non-GAAP financial measures with shareholders as they: better represent the ongoing economics of the business, reflect how we manage the business internally and set operational goals, and form the basis of our management incentive programs. Accordingly, we believe investors’ understanding of the Company’s financial performance is enhanced as a result of our disclosing these non-GAAP financial measures. Non-GAAP EPS should not be viewed in isolation or as a substitute for reported, or GAAP, EPS.
Purchase accounting and merger-related adjustments – Non-GAAP EPS excludes certain purchase accounting impacts such as those related to the merger with Biogen, Inc. (the “Merger”) and the acquisitions of Fumapharm AG, Conforma Therapeutics and Syntonix Pharmaceuticals. These charges relate to in-process research and development charges incurred upon the payment of future milestones and incremental charges related to the amortization of the acquired intangible assets. Excluding these charges allows management and investors an alternative view of our financial results “as if” the acquired intangible asset had been developed internally rather than acquired and, therefore, provides a supplemental measure of performance in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property.
Stock option expense – Non-GAAP EPS excludes the impact of our stock option expense recorded in accordance with SFAS No. 123R. We believe that excluding the impact of expensing stock options better reflects the recurring economic characteristics of our integrated business. We do include the P&L impact of restricted stock awards and cash incentives in our non-GAAP results.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the Company, please visit www.biogenidec.com.
Safe Harbor
This press release contains forward-looking statements about our expected revenues, earnings, cash flows, product sales, product development and other matters. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect. Important factors that could cause our actual results to differ include our continued dependence on our two principal products, AVONEX® (Interferon beta-1a) and RITUXAN® (rituximab), the uncertainty of success in commercializing other products including TYSABRI, the occurrence of adverse safety events with our products, the failure to execute our growth strategy successfully or to compete effectively in our markets, our dependence on collaborations over which we may not always have full control, possible adverse impact of government regulation and changes in the availability of reimbursement for our products, problems with our manufacturing processes and our reliance on third parties, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, the risks of doing business internationally and the other risks and uncertainties that are described in Item 1A Risk Factors in our most recent Form 10-Q filing with the SEC. These forward-looking statements speak only as of the date of this press release, and we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
Booming Clinical Trials Market in India
Filed under: Asia-Pacific, Biotech, Business, Data Management, Europe, Pharma
DUBLIN, Ireland (Newstron): Research and Markets has announced the addition of “Booming Clinical Trials Market in India” to their offering.
India has emerged as a strong base for clinical trials in recent times. Due to the multitude of benefits it offers, the country is fast growing as a centre for conducting clinical trials for many international companies. So we have launched this research report called “Booming Clinical Trials Market in India” to give first-hand information on the Indian clinical trials market. It investigates the key competitive advantages/disadvantages India has when it comes to conducting clinical trials in the country. The report also does a through study of the key factors which evaluate the country’s clinical trials, such as patient pool, patient recruitment, cost, time, government regulations, intellectual property, human resources, infrastructure and ethical issues.
India, with its huge patient base, low cost advantage, completion of clinical trials on time, improving infrastructure, and with a strong government support is witnessing a double digit growth in its clinical trials market. All major pharmaceutical companies and Clinical Research Organizations (CROs) have already started conducting their clinical trials in India, and with improving infrastructure, industry friendly regulations and trained workforce, the growth is only likely to increase in future.
However, to achieve its goal of becoming a global hub of clinical trials, the country will have to overcome challenges like unethical trials, delay in trial approval, inappropriate protection of clinical data, and lack of Good Clinical Practice (GCP) certified sites and investigators.
Key Findings
- Indian clinical trials market is expected to grow at a CAGR of nearly 36% between 2006 and 2011 to register revenues worth US$ 546 Million in future.
- One of the biggest advantages of conducting clinical trials in India is the availability of a large patient pool that can be recruited at much shorter time then it takes to recruit patients in the west.
- India by 2011 will be conducting more than 15% of the total global clinical trials.
- India presently lacks in GCP trained investigators (which are less than 1000). Their demand is projected to reach between 3000 and 6000 by 2010.
- India does not provide “Data Exclusivity” in clinical trials unlike the US and EU members.
- The salaries of a clinical data specialist and Medical writer in India are around 15% and 9% respectively of what they get in the US.
- The clinical trials market will drive the growth of the Diagnostics and Pathology Industry in India.
Key Issues and Facts Analyzed
- Evaluation of past, current and future market trends.
- Discussion about the factors driving the clinical research market.
- An analysis of the opportunities created by the market.
- A review on the government regulations on the market.
- An analysis of the major challenges faced by the market.
Key Players Analyzed
This section provides the overview, key facts financial information of prominent players in the Indian clinical trials market like Quintiles, Ranbaxy, Dr Reddy’s Laboratories, Roche, Pfizer etc.
Research Methodology Used
Information Sources
Information has been sourced from books, newspapers, trade journals, and white papers, industry portals, government agencies, trade associations, monitoring industry news and developments, and through access to more than 3000 paid databases.
Analysis Methods
The analysis methods include ratio analysis, historical trend analysis, linear regression analysis using software tools, judgmental forecasting, and cause and effect analysis.
Contents: 1. Analyst View 2. Global Clinical Trials Market 2.1 What are Clinical Trials? 2.2 Conducting Clinical Trials is becoming Costlier & Difficult 2.3 Clinical Research Outsourcing Market 2.3.1 North America 2.3.2 Europe 2.3.3 Latin America 2.3.4 Africa 2.3.5 Asia-Pacific 3. Indian Clinical Trials Market 4. Key Players 4.1 Quintiles Transnational Corp. 4.2 Pfizer Inc. 4.3 Roche Group 4.4 Dr. Reddy's Laboratories Ltd. 4.5 Sanofi-Aventis S.A. 4.6 Ranbaxy Laboratories Ltd. 4.7 GlaxoSmithKline plc 4.8 Eli Lilly & Company 4.9 Novo Nordisk A/S 4.10 iGATE Clinical Research International 4.11 ClinInvent Research Pvt. Ltd. 4.12 Reliance Clinical Research Services Pvt. Ltd. 4.13 SIRO Clinpharm Pvt. Ltd. List of Tables List of Figures
For more information visit http://www.researchandmarkets.com/reports/c73925
Contact:
Research and Markets Laura Wood, Senior Manager Fax: +353 1 4100 980 press@researchandmarkets.com
Source: Research and Markets Ltd.
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