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jbog

07/19/11 2:12 PM

#123590 RE: DewDiligence #123589

Novartis AG is no longer actively pursuing U.S. medical diagnostic-testing company Gen-Probe Inc., meaning Gen-Probe could end its sales process without a buyer, people familiar with the matter said.

Novartis appeared to be the only potential suitor left after other bidders, including Life Technologies Corp. and Thermo Fisher Scientific Inc., dropped out of the race for Gen-Probe last month, these people said.

That meant Novartis, the Swiss health-care giant, was less motivated as a potential buyer because it didn't face competition for Gen-Probe, which is based in San Diego and sells tests for AIDS and other sexually transmitted diseases, these people added.

Novartis, which has a partnership with Gen-Probe, was seen as keen on keeping Gen-Probe out of others' hands, the people familiar with the matter said. Another bidder may emerge and the sales process is ongoing, other people familiar with the matter said.

A Gen-Probe spokesman declined to comment.

In a phone interview Tuesday, Novartis chief executive Joe Jimenez declined to comment on whether Novartis had shown interest in Gen-Probe. Referring to acquisitions in general, he said: "We're going to remain disciplined acquirers. We've got to make sure we're not overpaying for assets."

"We've got a significant amount of debt. While we want bolt-ons that will boost our scale and presence" in Novartis' areas of business, "we're going to be sure we're disciplined in ensuring that value will be created for Novartis shareholders," Mr. Jimenez said.

Gen-Probe shares had run up substantially since news of the auction surfaced this spring, and its stock peaked above $86 per share in mid-May. The shares traded at $70 before news of the auction process leaked in April.

But since The Wall Street Journal reported in June that Novartis was the only bidder left for Gen-Probe, the shares have fallen and were trading Tuesday monring at $64.03 per share, giving it a market capitalization of about $3.1 billion.

Spokespeople for Novartis and the other, past bidders either declined to comment or couldn't immediately be reached.

People close to the auction process have said Gen-Probe was seeking a price in the mid-80s per share or higher, but a number of bidders balked at such a valuation. It is unlikely that any of those bidders will reemerge unless the asking price falls to a number they find attractive, the people familiar said.

Medical diagnostic companies have recently been popular targets for health-care companies looking for new avenues of growth. Thermo Fisher in May agreed to buy closely held allergy-testing company Phadia AB for $3.5 billion. Danaher Corp. earlier agreed to buy Beckman Coulter, another medical-testing outfit, for $5.8 billion.
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DewDiligence

07/20/11 9:03 AM

#123633 RE: DewDiligence #123589

According to NVS’ 2Q11 CC, the Elinogrel phase-3 trial in ACS (#msg-53876832) is on hold until NVS sees the FDA response to the Brilinta NDA, which has a PDUFA date today.
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DewDiligence

01/13/12 6:31 AM

#134956 RE: DewDiligence #123589

NVS Cuts 2,000 Jobs—Drops Elinogrel and Oral Calcitonin

[Elinogrel is a Plavix-like drug for ACS (licensed from Portola) whose future had been in doubt (#msg-65338933). Oral calcitonin was being developed in collaboration with EMIS and Nordic Bioscience, but the program had been on life support since the failure of a phase-3 trial in 2010 (#msg-52568603).

The main impetus for NVS' layoff, however, is the looming patent expiration of Diovan and the recent setback with Tekturna, which may be withdrawn from the market (#msg-70148742). All told, the changes mentioned in this PR will save $450M per year in pre-tax operating expenses.]


http://www.novartis.com/newsroom/media-releases/en/2012/1577296.shtml

›January 13, 2012 07:15 CET

›Novartis to restructure US business to strengthen competitive position in light of loss of Diovan patent and announces charge for Rasilez/Tekturna

• US General Medicines restructuring results in reduction of 1,960 positions

• Action reflects impending loss of Diovan patent exclusivity in US and expected impact on worldwide sales of Rasilez/Tekturna after ALTITUDE study termination

• US restructuring to lead to an exceptional charge of USD 160 million in the first quarter of 2012 and to annual savings of approximately USD 450 million by 2013

• Reassessment of future sales potential of Rasilez/Tekturna leads to an exceptional charge of approximately USD 900 million in fourth quarter 2011

• In addition, as part of ongoing portfolio review, Novartis to take an exceptional charge of approximately USD 160 million related to termination of PRT128 (elinogrel) and SMC021 (oral calcitonin) programs

Basel, January 13, 2012 - Novartis Pharmaceuticals announced today that the company plans to strengthen its long-term competitive position in anticipation of the Diovan (valsartan) patent expiration and an expected reduction in demand for Rasilez/Tekturna (aliskiren) following termination of the ALTITUDE clinical study. The company will reduce its cost base with the current restructuring focused on the US market.

"We recognize that the next two years will be challenging in the Pharmaceuticals Division and we are proactively making these changes to further focus our pipeline on the best opportunities and align our market position on our growth brands," said David Epstein, Division Head of Novartis Pharmaceuticals. "These are difficult but necessary decisions that will free up resources to invest in the future of our business which we view as well suited to bring new valuable therapies to patients and payors."

A central element of the plan is a restructuring of the General Medicines business in the important US market, where Novartis Pharmaceuticals will continue to focus on expanding its presence in specialty businesses aligned with the product portfolio and pipeline. As a result, the field force is planned to be reduced by approximately 1,630 positions and headquarters functions will realign to support the new organization, resulting in an additional reduction of approximately 330 positions. The changes are planned to take effect in the second quarter of 2012, and associates will be notified in early April, 2012. All reductions will be handled in a manner consistent with the Novartis commitment to fair and respectful treatment of associates. Outplacement and other support services will be available to impacted associates as well as redeployment opportunities, where they exist, within the Novartis Group of companies.

The restructuring was prepared to respond to the loss of patent exclusivity for Diovan, the market-leading hypertension medication, expected in the US in September 2012. The plan has been accelerated after the ALTITUDE study was halted following the recommendation from the Data Monitoring Committee overseeing the trial. The study was investigating Rasilez/Tekturna in a high-risk population of patients with type-2 diabetes and renal impairment. As a precautionary measure Novartis Pharmaceuticals ceased all promotion of Rasilez/Tekturna-based products for use in combination with an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Novartis Pharmaceuticals, in consultation with health authorities, is now recommending that hypertensive patients with diabetes should not be treated with Rasilez/Tekturna in combination with an ACE-inhibitor or ARB. Patient safety is the highest priority for Novartis and we are in continuing dialogue with health authorities worldwide to establish the most appropriate next steps.

The restructuring is expected to result in an exceptional charge of approximately USD 160 million to be recognized in the results for the first quarter of 2012. It is planned to produce full-year savings of approximately USD 450 million as of 2013, about half of which is expected to be realized in 2012 due to reorganization timelines. Together with ongoing productivity programs, the company plans to continue to ensure that the product portfolio and research pipeline are fully invested in to sustain growth.

A reassessment of the future sales potential of Rasilez/Tekturna in light of the ALTITUDE results has led to an exceptional charge of approximately USD 900 million (of which approximately USD 800 million are non cash) to be recognized in the fourth quarter of 2011. The charge comprises impairments to intangible and manufacturing assets and excess inventory together with trial wind down and other exit costs. The accounting charge is triggered by lower sales expectations and does not seek to anticipate the results of our ongoing discussions with health authorities concerning Rasilez/Tekturna.

In addition, Novartis Pharmaceuticals will recognize an exceptional charge of approximately USD 160 million in the fourth quarter of 2011 related to termination of the PRT128 (elinogrel) and SMC021 (oral calcitonin) programs.‹