Sanofi to make formal Genzyme offer

(Reuters) – France’s Sanofi-Aventis (SASY.PA) plans to make a formal offer of up to $18.7 billion for Genzyme (GENZ.O) after its informal overture failed to strike interest, sources familiar with the situation said on Wednesday.

The board of Sanofi met in Paris on Wednesday and authorized management to make a formal offer of up to $70 per share for Genzyme, sources said.

Sanofi has bank commitments of funding that would allow it to raise that bid if needed, one source said. A second source cautioned that no formal proposal had been made yet and plans could still change.

Genzyme has a market capitalization of about $18 billion. At $70 per share, Sanofi would be offering a premium of roughly 30 percent over what the price of Genzyme’s stock was before news of takeover interest emerged.

The Wall Street Journal, citing people close to Genzyme, suggested that about $75 a share could be sufficient to win the support of Genzyme’s board.

Sanofi, which is scheduled to report second-quarter earnings on Thursday, declined to comment. Genzyme could not be immediately reached for comment.

Shares of Genzyme gained 5 percent to $71.20 in extended trading on Wednesday after news of the board meeting.

Analysts see Sanofi in greater need of a major acquisition than some of its rivals as it braces for generic competition for some of its key products.

Last week, Sanofi lowered its view for 2010 earnings per share after U.S. regulators approved a generic form of the Lovenox blood thinner, its No. 2 product last year.

Genzyme’s biggest-selling drug is Cerezyme, a treatment for Gaucher disease, a rare genetic disorder. Promising drugs in late stage development include a treatment for multiple sclerosis.

Orphan drugs — those that treat small numbers of patients but command high prices — are much less amenable to generic competition than pills and are therefore attractive acquisition candidates.

BEAR HUG LETTER EXPECTED

Sanofi’s proposal was expected to come in the form of a publicly disclosed “bear hug” letter that would lay out proposed takeover terms and try to pressure Genzyme to open negotiations, the first source said.

Genzyme failed to respond to Sanofi’s informal overture, sources previously told Reuters. Genzyme, which is trying to sell three non-core businesses, is not looking to sell the company, sources previously said.

Reports that Sanofi was making a run at Genzyme surfaced on Friday. The news has sent the U.S. company’s shares up about 30 percent since then as investors figured the company would garner a hefty premium for its portfolio of expensive treatments for rare genetic disorders and a pipeline of drugs in development.

Analysts see Genzyme fetching anywhere from $60 to $85 a share, depending on their view of the value of the company’s experimental drugs, the risks associated with its recovery from a manufacturing crisis and the entry of other bidders.

Some company watchers, however, focus on a narrower price range and say Genzyme shareholders may be willing to accept a price of $70 to $80 per share, particularly newer investors who were drawn to the company when it was targeted by activist investor Carl Icahn.

Sanofi’s approach comes on the heels of a turbulent two years for Genzyme and its chief executive, Henri Termeer, who is expected to step down within the next year or two.

Earlier this year, Termeer fought off a threatened proxy fight by reaching settlements with investors Carl Icahn, who now has two representatives on the company’s board, and Ralph Whitworth of Relational Investors LLC, who also sits on the board.

The Wall Street Journal said Britain’s Glaxo (GSK.L) had also recently made “a very casual approach” to Genzyme, but industry insiders and analysts said that Glaxo Chief Executive Andrew Witty, with a reputation for caution on M&A, was unlikely to chase Genzyme.

(Reporting by Jessica Hall; Editing by Gary Hill, Phil Berlowitz, Gary Hill)

UPDATE 1-Sanofi Q2 beats market; mum on Genzyme bid talk

PARIS, July 29 (Reuters) – Sanofi-Aventis (SASY.PA) beat second-quarter earnings expectations as it beefed up sales and tightened its R&D spending, but the French drugmaker gave no hint in its results statement of any acquisition plans.

Sources told Reuters late on Wednesday that Sanofi plans to make a formal offer of up to $18.7 billion, or $70 per share, for U.S. biotech Genzyme (GENZ.O) as it seeks to replenish its drug pipeline and make up for the loss of patent protection on blockbuster drugs in the years through 2013. [ID:nN28226612]

Quarterly earnings beat the average outcome of a Reuters poll on all fronts as Sanofi tightened spending, and as sales were driven by its diabetes division, emerging markets and consumer health.

Business net income rose 7.6 percent to 2.478 billion euros ($3.22 billion) versus the poll’s average of 2.32 billion euros. Earnings per share climbed 8 percent to 1.90 euros versus the poll’s 1.78 euros.

Sales increased 4.6 percent to 7.783 billion euros even as competition grew from generic copies of bloodthinner Plavix and cancer drug Eloxatin, and as vaccine sales declined.

The U.S. health regulator’s approval of a generic to bloodthinner Lovenox led Sanofi last week to cut its earnings per share forecast to between stable and 4 percent lower at constant exchange rates from 2-5 percent growth against 2009.

For 2013, Sanofi expects sales to be at least at 2008′s level of 27.57 billion euros, and business net income to be similar to the 2008 level of 7.314 billion euros.

Those forecasts take into account the arrival of a Lovenox copy as well as government healthcare spending cuts, and exclude acquisitions above 1 billion euros, like consumer health company Chattem and a stake in Merial animal health that Sanofi did not already own.

Sanofi expected cost savings, including on R&D, to exceed 1 billion euros at constant exchange rates this year from the 2008 level and compared with a 2013 savings goal of 2 billion euros.

MUM ON MERGERS

In its earnings statement on Thursday, Sanofi did not comment on its acquisition strategy for which CEO Chris Viehbacher has set a limit of 15 billion euros, though never entirely dismissing a bigger deal.

Last year, Sanofi invested 6.6 billion euros on 33 new partnerships and acquisitions and has said it would do a similar number of deals this year to further branch out its business and address unmet medical needs.

A bigger move could be on the cards, however, as more than a fifth of Sanofi’s 2008 drug sales — excluding a generic Lovenox — face patent expiries to 2013, and its drug portfolio can’t offset that loss.

Sanofi’s net debt rose to 6.17 billion euros in the first half from 4.14 billion euros at end-2009, while net cash from operating activities stood at 4.2 billion euros.

Sanofi shares closed 0.6 percent higher at 45.43 euros on Wednesday. The stock is down about 17.5 percent so far this year, underperforming a 1.9 percent dip in the DJ health index .SXDP.

Sanofi-aventis video Q&A: CEO Chris Viehbacher comments on earnings for Q2 2010

PARIS–(Business Wire)–
Sanofi-aventis, one of the world`s largest diversified healthcare companies,
reports earnings for the second-quarter of 2010. CEO Chris Viehbacher comments
on Q2 earnings and outlook.

Use these links to watch the video interview in the format of your choice:

Flash Player:

http://www.eurobusinessmedia.com/interviewFlash.php?id_article=555

Windows Media Player:

http://www.eurobusinessmedia.com/interviewWmp.php?id_article=555

Use this link to read the interview transcript:

http://www.eurobusinessmedia.com/transcript.php?id_article=555

Topics covered in the interview include:

– Group performance
– Diabetes
– Consumer Health Care
– Oncology
– Emerging Markets
– Merial-Intervet
– Lovenox
– R&D
– Pricing
– External growth

About sanofi-aventis:

Sanofi-aventis, a leading global diversified healthcare company, discovers,
develops and distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).

Company website: http://en.sanofi-aventis.com/home.asp

Sanofi-aventis
Investor Relations :
IR@sanofi-aventis.com
or
Media Relations :
MR@sanofi-aventis.com

Copyright Business Wire 2010

Interview vidéo : le DG de Sanofi-aventis, Chris Viehbacher, commente les résultats du 2ème trimestre 2010

PARIS–(Business Wire)–
Sanofi-aventis, l`un des leaders mondiaux de la santé, publie ses résultats pour
le 2ème trimestre 2010. Le Directeur Général Chris Viehbacher commente les
résultats et les perspectives.

Cliquer sur le lien ci-dessous pour visionner l`interview au format de votre
choix:

Flash Player:

http://www.eurobusinessmedia.com/interviewFlash.php?id_article=554

Windows Media Player:

http://www.eurobusinessmedia.com/interviewWmp.php?id_article=554

Cliquer sur le lien ci-dessous pour lire la transcription de l`interview:

http://www.eurobusinessmedia.com/transcript.php?id_article=554

Au sommaire de l`interview:

– Performance du Groupe
– Diabète
– Santé Grand Public
– Oncologie
– Marchés Emergents
– Merial-Intervet
– Lovenox
– R&D
– Prix
– Croissance externe

A propos de sanofi-aventis :

Sanofi-aventis est un leader global de la santé qui recherche, développe et
diffuse des solutions thérapeutiques pour améliorer la vie de chacun. Le Groupe
est coté en bourse à Paris (EURONEXT : SAN) et à New York (NYSE : SNY).

Site web de la société: http://www.sanofi-aventis.com/accueil.asp

Sanofi-aventis
Contact Investisseurs :
IR@sanofi-aventis.com
ou
Contact Médias :
MR@sanofi-aventis.com

Copyright Business Wire 2010

Teva shares sink on fears of Copaxone competition

TEL AVIV, July 25 (Reuters) – Shares in Teva Pharamaceutical Industries (TEVA.TA) fell sharply on Sunday on fears of looming competition for its blockbuster multiple sclerosis drug Copaxone.

Shares in Teva, the world’s biggest generic drugmaker, were down 5.8 percent to 198.80 shekels at 0933 GMT, after its Nasdaq shares (TEVA.O) slid 8.6 percent to $49.38 on Friday.

U.S. health regulators approved on Friday the first generic version of widely used Sanofi-Aventis (SASY.PA) blood clot treatment Lovenox to the Sandoz generic drug unit of Switzerland’s Novartis AG (NOVN.VX), which is allied with smaller partner Momenta Inc (MNTA.O). [ID:nN23123382]

The approval of the complex medicine has spooked Teva investors, who fear the FDA now might be willing to approve a generic version of Copaxone, which like Lovenox is complicated to make.

“If Momenta succeeded in getting approval for one complex molecule it’s possible it will also get approval for Copaxone, and soon,” Bank Hapoalim analyst David Levinson said.

Momenta and Novartis are seeking U.S. approval of a generic Copaxone, and Momenta said on a conference call on Friday it was working with the FDA on its Copaxone application.

Harel Finance analyst Steven Tepper said he believed the path to approval of a generic version of Copaxone is long and complicated and called the comparison with Lovenox weak.

“The complexity of Copaxone is different from that of Lovenox and the process of approval is expected to be different,” Tepper said. “Like Lovenox, the process for approving a generic version of Copaxone is expected to be long and take about five years.”

Teva said on Friday any potential generic version of Copaxone would need to be evaluated with full-scale clinical trials, given Copaxone’s complexity.

Copaxone is patent protected until 2014, and Momenta and Sandoz will have to persuade the courts they are not violating the patent, Harel Finance’s Tepper said.

Teva is also seeking to sell a generic form of Lovenox and Bank Hapoalim’s Levinson said investors questioned why the company had not received approval yet.

Teva said it believed its generic Lovenox met FDA criteria and could be approved.

“There is no doubt we are at the beginning of the end for Copaxone,” Levinson said.

Even if Copaxone sales continue to grow in the coming year or two, Teva’s shares will be volatile because the drug represents about 20 percent of Teva’s sales, he said.

“We believe these sharp drops represent a long-term buying opportunity,” Levinson said, who rates Teva outperform. “We believe the share is trading at a low price earnings multiple relative to the industry.”

Harel Finance’s Tepper maintained a buy rating for Teva but lowered his price target by $2 to $64 a share. ($1 = 3.85 shekels) (Editing by Karen Foster)

Positive Results from Phase II VTE Prophylaxis Study with TB-402 (Anti-Factor VIII) Presented at the 21st International Congress on Thrombosis in Milan, Italy

Study demonstrates TB-402 superior antithrombotic activity to enoxaparin
LUND, Sweden & LEUVEN, Belgium–(Business Wire)–
BioInvent International AB (OMXS: BINV) and ThromboGenics NV (Euronext Brussels:
THR) announce that the positive results from a Phase II trial of TB-402
(Anti-Factor VIII antibody) were presented at the 21st International Congress on
Thrombosis (ICT) in Milan, Italy yesterday. TB-402 is a novel, long acting
anticoagulant that is being developed as a single injection for the prevention
of venous thromboembolism (VTE) following orthopaedic surgery.

The data were presented by Professor Peter Verhamme (University of Leuven,
Belgium) in a presentation entitled, “Single intravenous administration of
TB-402 for the prophylaxis of VTE after total knee replacement surgery.” The
Phase II results showed the superior antithrombotic activity of TB-402, when
compared to enoxaparin (Lovenox®: sanofi-aventis). The study showed that the two
drugs had comparable safety. Enoxaparin is currently the standard treatment to
prevent VTE in this setting. VTE encompasses both deep venous thrombosis (DVT)
and pulmonary embolism (PE).

The Phase II trial was a multicenter, dose-escalating, randomised, open-label
trial, evaluating TB-402 against enoxaparin for the prophylaxis of VTE after
knee surgery. All patients received enoxaparin 40mg pre-operatively. Post
operatively, patients were randomized in a sequential cohort design to one of
three doses of TB-402 (0.3mg/kg, 0.6mg/kg or 1.2mg/kg) or enoxaparin 40mg (3:1;
n=75 per group). The study enrolled a total of 316 patients across 30 centers in
Europe.

TB-402 was administered as a single intravenous bolus injection 18-24 hours
after orthopaedic surgery, whereas enoxaparin was given as a 40mg subcutaneous
injection every day for a period of at least 10 days. The primary efficacy
endpoint was based on measuring all occurrences of VTE in patients by Day 7-11,
whether they were symptomatic or asymptomatic. The primary safety endpoint was
the number of patients with major or clinically relevant non-major bleeding from
randomisation until the end of the study at 3 months.

Professor Verhamme presented the pooled data for the TB-402 treated group, which
showed that 47 out of 218 (or 22%) patients experienced VTE; this compares to
the enoxaparin treated group, where 30 out of 77 (or 39%) patients experienced
VTE (p<0.05). The difference of reduction in VTE between the two groups is
statistically significant. The study also showed that TB-402 and enoxaparin had
a similar safety profile.

Svein Mathisen, CEO of BioInvent, commented, “We are pleased to have Phase II
results for TB-402 presented at this internationally recognized event,
reinforcing the unique profile of this drug candidate which we expect to
generate interest from pharmaceutical partners. We are excited by the
opportunity that TB-402 provides in the anticoagulation marketplace due to its
attractive dosing opportunities and half life and the potential benefits this
will provide for patients and healthcare providers alike.”

Patrik De Haes, CEO of ThromboGenics, also commented, “We are very pleased by
Professor Verhamme`s presentation of the exciting TB-402 Phase II data at this
important conference. VTE is a major clinical problem that carries considerable
costs both to patients and healthcare providers, and we are very encouraged that
TB-402 has demonstrated such an attractive profile compared to the current gold
standard. These data have reinforced our view that a product that is able to
reduce the incidence of VTE significantly in just a single post-operative
injection could represent an exciting opportunity for a potential partner and
allow us to bring TB-402 to market.”

Notes to Editors:

About TB-402

TB-402 has the potential to be a very important new entrant into the
anticoagulant market. TB-402 is a recombinant human monoclonal antibody that
partially inhibits Factor VIII, a key component of the coagulation cascade. This
novel mode of action is expected to be an effective and safe treatment
alternative with less need for patient monitoring. In addition, TB-402 is a
long-acting agent, which means it could be given as a single dose to prevent the
development of DVT in patients undergoing surgery. This simple approach to
prophylaxis would be an attractive option, as all current anticoagulant
treatment options require daily treatment for up to several weeks.

About Deep Vein Thrombosis (DVT)

DVT is caused when a blood clot forms in a deep vein, most commonly in the deep
veins of the lower leg. DVT is a major public health issue and it is estimated
that in the U.S. alone, more than 600,000 patients are treated for venous
thromboembolisms (VTE) such as DVT or pulmonary embolism (PE) each year.1
Moreover, DVT and PE together may be responsible for more than 100,000 deaths in
the U.S. each year.2

It is estimated that by 2015, 1.4 million patients will undergo knee replacement
and 600,000 patients will undergo hip replacement in the U.S. if current trends
persist.3 Patients undergoing hip replacement or knee surgery are particularly
at risk of developing DVT and all patients are therefore treated with
anticoagulants prophylactically in order to reduce the risks of blood clots. The
annual sales of anticoagulants worldwide are over $5 billion. Nevertheless,
available anticoagulants are still inconvenient and associated with an increased
risk of bleeding. Improved anticoagulants are therefore required. In particular,
agents that allow for improved ease of administration (without requirement for
daily dosing and frequent dose adjustment) would fill a significant unmet need.

About BioInvent

BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a
research-based

pharmaceutical company that focuses on developing antibody drugs. The Company
currently has four clinical development projects within the areas of thrombosis,
cancer and atherosclerosis. The Company has signed various strategic alliances
to strengthen the product pipeline and increase the likelihood of success. These
partners include Genentech, Human Genome Sciences, Roche and ThromboGenics.

The company`s competitive position is underpinned by an in substance patented
antibody development platform. The scope and strength of this platform is also
utilised by partners, such as Bayer HealthCare, Daiichi Sankyo, Mitsubishi
Tanabe, UCB and XOMA.

More information is available at www.bioinvent.com.

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on the discovery and
development of innovative medicines for the treatment of eye disease. The
Company`s lead product Microplasmin has completed its first Phase III clinical
trial for the non-surgical treatment of back of the eye diseases. Microplasmin
is also being evaluated in Phase II clinical development for additional
vitreoretinal conditions. In addition, ThromboGenics is developing novel
antibody therapeutics in collaboration with BioInvent International; these
include TB-402 (anti-Factor VIII), a long acting anti-coagulant in Phase II, and
TB-403 (anti-PlGF) in Phase I for cancer in partnership with Roche.

ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on
Eurolist by Euronext Brussels under the symbol THR. More information is
available at www.thrombogenics.com.

Legal disclaimer

This press release contains statements about the future, consisting of
subjective assumptions and forecasts for future scenarios. Predictions for the
future only apply as of the date they are made and are, by their very nature, in
the same way as research and development work in the biotech segment, associated
with risk and uncertainty. With this in mind, the actual outcome may deviate
significantly from the scenarios described in this press release.

Information disclosed in this press release is provided herein pursuant to the
Swedish Securities Markets Act and/or the Swedish Financial Instruments Trading
Act. The information was submitted for publication at 7.30 a.m. CET, on 9 July,
2010.

1 Barclays Capital Equity Research Report on New Anticoagulants, August 5, 2009

2 “The Surgeon General`s Call to Action to Prevent Deep Vein Thrombosis and
Pulmonary Embolism,” September 15, 2008, p.1.

3 “Changes in Surgical Loads and Economic Burden of Hip and Knee Replacements in
the US: 1997-2004,” Sunny Kim, Arthritis & Rheumatism (Arthritis Care &
Research), April 15, 2008; 59:4, pp. 481-488.

BioInvent International AB
President & CEO
Svein Mathisen, +46 (0)46-286 85 67
Mobile: +46 (0)708-97 82 13
svein.mathisen@bioinvent.com
or
Executive Vice President
Cristina Glad, +46 (0)46-286 85 51
Mobile: +46 (0)708-16 85 70
cristina.glad@bioinvent.com
or
College Hill (media enquiries)
Katja Toon, Justine Lamond, Anastasios Koutsos, +44 (0)20 7866 7857
bioinvent@collegehill.com
or
Erik Clausen (US), +1 415-230-5385
erik.clausen@collegehill.com
or
ThromboGenics NV
Chief Executive Officer
Patrik De Haes, MD, +32 (0) 16 75 13 10
patrik.dehaes@thrombogenics.com
or
Clinical Director Europe
Andy De Deene, MD, +32 (0) 16 75 13 10
andy.dedeene@thrombogenics.com
or
Citigate Dewe Rogerson
Amber Bielecka, David Dible, Nina Enegren, +44 (0) 207 638 95 71
amber.bielecka@citigatedr.co.uk

Copyright Business Wire 2010