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CLVS

Clovis

$34.76

-0.59 (-1.67%)

16:38
10/04/16
10/04
16:38
10/04/16
16:38

Clovis Oncology, Lonza enter manufacturing services pact for rucaparib

On October 3, Clovis Oncology and Lonza entered into a manufacturing services agreement for the long term manufacture and supply of the active pharmaceutical ingredient for rucaparib, according to a regulatory filing. The terms and conditions of the agreement are contingent upon the approval by the U.S. Food and Drug Administration of the initial New Drug Application for rucaparib, unless triggered earlier by Clovis. Clovis and Lonza are parties to a development and manufacturing agreement, dated February 8, 2013, as amended, under which Lonza has supplied rucaparib API for clinical development. The agreement provides that Lonza will be a non-exclusive manufacturer of the rucaparib API during the term of the agreement, which expires on December 31, 2025, unless extended by mutual written consent of the parties. Under the agreement, Lonza will construct, in an existing Lonza facility, a production train that will be exclusively dedicated to the manufacture of the rucaparib API. The dedicated production train will provide manufacturing capacity to meet Clovis' currently anticipated needs for commercial supply of rucaparib API. Clovis is obligated to make scheduled capital program fee payments towards capital equipment and other costs associated with the construction of the dedicated production train and, once the facility is operational, Clovis is obligated to pay a fixed facility fee each quarter for the duration of the agreement. Pursuant to the terms of the agreement, Lonza will manufacture and store an advanced intermediate to be used in the subsequent production of the rucaparib API. Clovis will pay fixed fees on a per kilogram basis for quantities of the advanced intermediate and the rucaparib API ordered by Clovis under the agreement, subject to certain adjustments. Until the dedicated facility is completed and operationally qualified, Lonza will manufacture the rucaparib API in existing Lonza facilities at pricing established in the agreement.

  • 06

    Nov

  • 23

    Feb

CLVS Clovis
$34.76

-0.59 (-1.67%)

09/21/16
09/21/16
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Monsanto (MON) upgraded to Overweight from Neutral at JPMorgan with analyst Jeffrey Zekauskas saying the risk in the shares is "less than what the market assumes." 2. Barclays (BCS) upgraded to Buy from Hold at HSBC citing the pending disposal of non-core businesses and resulting value creation. 3. Etsy (ETSY) upgraded to Buy from Neutral at Monness Crespi with the firm's analyst believing that Etsy shares can still move higher and sees a solid opportunity for upward revisions from improving conversion rates due to enhanced search and mobile functionality, expanding take rates, and advanced cross-boarder commerce capabilities with vendors. 4. Clovis (CLVS) upgraded to Outperform from Neutral at Credit Suisse with analyst Kennen MacKay saying the potential for a takeover "outweighs concerns surrounding patent life, limited experience in platinum resistant/refractory patients, and PARPi competition." 5. Jabil Circuit (JBL) upgraded to Buy from Neutral at UBS with analyst Steven Milunovich saying the company's cash flow is nearing an inflection amid an upturn in its Apple (AAPL) business. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/21/16
JANY
09/21/16
DOWNGRADE
JANY
Neutral
Clovis downgraded to Neutral from Buy at Janney Capital
09/21/16
JANY
09/21/16
DOWNGRADE
Target $36
JANY
Neutral
Janney downgrades Clovis with buyout speculation at 'fever pitch'
Janney Capital analyst Roy Buchanan downgraded Clovis Oncology (CLVS) to Neutral from Buy with an increased fair value estimate of $36. Clovis is up 17c to $35.00 in late morning trading. In a research note partially titled, "May Be Right, May Be Crazy - M&A Speculation At Fever Pitch," Buchanan says there is a "finite chance" that Clovis will need to market its PARP inhibitor rucaparib by itself. He believes a late-2016 approval for rucaparib is likely. The analyst attributes his increased fair value estimate to "acquisition optionality." Reports of Takeda's (TKPYY) reserving up to $15B for acquisitions and Medivation's (MDVN) takeout have given Clovis shares a lift, Buchanan tells investors. The analyst adds that rumors surfaced yesterday of potential interest in the company from Eli Lilly (LLY).
10/04/16
PIPR
10/04/16
NO CHANGE
Target $42
PIPR
Neutral
Clovis price target raised to $42 from $14 at Piper Jaffray
Piper Jaffray analyst Steven Breazzano raised his price target for Clovis Oncology (CLVS) to $42 after taking a "comprehensive look" at the PARP inhibitor landscape in ovarian cancer and beyond. The company's PARP inhibitor rucaparib has demonstrated an active profile in ovarian cancer and all signs point to an approval in the 3L+ setting early next year, Breazzano tells investors in a research note. The analyst, however, believes the ultimate key is success in the earlier maintenance setting, and he thinks the race may still be Tesaro's (TSRO) niraparib's to lose. Breazzano keeps a Neutral rating on Clovis.

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