TSRO TESARO Receives Complete Response Letter

[tomsylver]

TESARO Receives Complete Response Letter for Rolapitant IV from U.S. FDA

• No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional clinical studies are not required
  
• Investor conference call and webcast scheduled for tomorrow at 8:30AM ET

WALTHAM, Mass., Jan. 11, 2017 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the rolapitant IV New Drug Application (NDA) for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.

FDA requested additional information regarding the in vitro method utilized to demonstrate comparability of drug product produced at the two proposed commercial manufacturers for rolapitant IV that were included in the NDA. TESARO is working expeditiously to provide the requested information.

The CRL did not identify concerns related to the safety or efficacy of rolapitant IV or request additional clinical studies. No concerns were raised regarding the active pharmaceutical ingredient (API), which is also used for the VARUBI® (rolapitant) oral product.

TESARO identified potential deficiencies at the original contract manufacturer for rolapitant IV drug product, secured a second drug product supplier and included data from this manufacturer in the NDA. During the NDA review, FDA requested and TESARO provided in vitro data to demonstrate comparability of drug product made at the two manufacturing sites.

"Chemotherapy-induced nausea and vomiting (CINV) remains a significant unmet need, with more than half of patients treated with emetogenic chemotherapy experiencing this debilitating side effect," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "TESARO is committed to bringing this new intravenous formulation of rolapitant to physicians and patients to enable additional flexibility and choice of antiemetic regimens, and we plan to address FDA's questions expeditiously and complete this application, which we expect to enable approval in the first half of 2017."

Investor Conference Call and Webcast

TESARO will host a conference call to discuss this announcement tomorrow, January 12, at 8:30 A.M. Eastern time. The live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing [phone] (U.S. and Canada) or [phone] (international). A replay of the webcast will be archived on the Company's website for 30 days following the call.

About VARUBI® (rolapitant)

VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. NK-1 receptors are highly concentrated in the brain and bind neurokinin substance P. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. A Positron Emission Tomography (PET) study with rolapitant in normal, healthy volunteers demonstrated that rolapitant crosses the blood brain barrier and occupies brain NK-1 receptors at high levels for up to 120 hours. VARUBI has a half-life of approximately seven days, which may contribute to the ability of a single dose of VARUBI to cover the entire delayed CINV Phase (25-120 hours). VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.

TESARO licensed exclusive rights for the development, manufacture, commercialization and distribution of VARUBI (rolapitant) from OPKO Health, Inc.

About TESARO

TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding TESARO's plans to meet with FDA, provide the data requested in the complete response letter, bring the IV formulation of rolapitant to physicians and patients, and our expectation that our response to the complete response letter will enable approval of rolapitant IV in the first half of 2017 without additional clinical studies. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our future results, performance, or achievements, including the potential approval and launch of the IV formulation of rolapitant, to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in drug development and the execution and completion of clinical trials, uncertainties surrounding our ongoing discussions with and potential actions by the FDA, uncertainties regarding the ultimate regulatory approval of the IV formulation of rolapitant, risks related to manufacturing and supply of the IV formulation of rolapitant, and other matters that could affect the ultimate approval, availability or commercial potential of the IV formulation of rolapitant. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2015, and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016.



Investor/Media Contact:

Jennifer Davis
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or [e-mail]

[tomsylver]

The year begins as well as the last had finished.

[tomsylver]

TESARO identified potential deficiencies at the original contract manufacturer for rolapitant IV drug product, secured a second drug product supplier and included data from this manufacturer in the NDA. During the NDA review, FDA requested and TESARO provided in vitro data to demonstrate comparability of drug product made at the two manufacturing sites.

That reminds me of Rayaldee and Catalant.

[sgard434]

I was afraid of this. It will get approval eventually but both tsro and opk stock price will probably take a hit until the manufacturing issues are resolved. In the last year or so The FDA is using NDAs as a way to insure good manufacturing practices and it does more harm to the drug companies than the manufacturer. Damn we just didnt need this right now...

[sgard434]

I was not impressed with Steve Rubin's presentation at the JPM conference. He thought the IV Varubi PDUFA was next week. Is he not paying attention to anything that impacts the stock price of OPK?

[sgard434]

After giving this more thought I realized that Steve Rubin has probably been all consumed with planning the statistical analysis with PFE for hGH so they can submit to FDA. And then he had to travel to the JPM conference. So maybe he's tired and not quite on top of everything he normally would be?

[miamianne67]

"I realized that Steve Rubin has probably been all consumed with planning the statistical analysis with PFE for hGH so they can submit to FDA. And then he had to travel to the JPM conference. So maybe he's tired and not quite on top of everything he normally would be? " sgard

SGARD, if so, is there no other talent in the company? YES there is. Henderson. Why not? Miami

[Deleted]

Rubin is an idiot if he thought PDUFA was next week.... that's being kind.. EVP of 5B company doesn't make that kind of mistake..

[Doe]

I think we have to give these guys a break.  We are on the outside looking in and have no idea what it takes to run the company on a day to day basis.    He should be focused on creating a good business, not the price of the stock.  The stock market is insane and manipulated, especially this stock.  Why should he waste one second of brain power trying to control something that is uncontrollable.

[Deleted]

TSRO on CC:

Varubi IV

manufacturing issue.. class 1 resubmission .. 2 month delay in approval.. won't affect launch..

hey sounds familiar

[stcks]

The FDA said earlier that this is how they are working to fix problems that they find in manufacturing. Why is anyone really surprised?

We now have PDUFA date. We need to have the PDUFAPMFD. "Prescription Drug User Fee Act Plus Manufacturer's F****p Date" PDUFA + 60 Days.

A keen example of how these little things done In Washington adds cost to everything we do in the real world.

Saying all that, I do not see how it will not affect launch?

[Deleted]

if it's just 2 mo delay, I can see no real impact on launch.. they were considering 2h launch right? w/ 2 mo delay, they still could launch in 2h... (more or less in general time frame, and not exact days)...

[stcks]

As I read the CLR information. The only dates listed is the following.

The applicant will have 30 days from the date of the notification to explain why the application should not be withdrawn and to request an extension of time in which to resubmit the application. FDA will grant any reasonable request for an extension. If the applicant does not respond to the notification within 30 days, the application will be deemed to be withdrawn.

www.gpo.gov/fdsys/pkg/FR-2008-07-10/pdf/E8-15608.pdf

[icemandios]

Jan 12, 2017 14:27:03 GMT @topgun1967 said:

if it's just 2 mo delay, I can see no real impact on launch.. they were considering 2h launch right?

I listened to the CC this morning, and the spokesperson said TSRO had planned for a first half 2017 launch. Went on to say they are now looking at a 2nd half launch.

[tomsylver]

www.investors.com/news/technology/tesaro-stock-rebounds-despite-fda-holdup-on-anti-nausea-med/?yptr=yahoo

Tesaro Stock Rebounds Despite FDA Holdup On Anti-Nausea Med

Despite an FDA holdup, Tesaro's (TSRO) post-chemo, anti-nausea IV drug could garner approval by mid-2017, Leerink and Credit Suisse analysts said Thursday as Tesaro stock recovered from two days in the red.

On the stock market today, Tesaro stock rose 0.74% to 146.98. But shares closed down an average 1% over the past two days after hitting a 148.84 buy point out of a consolidation on Monday. Shares are now trading 1.2% below that entry point.

Tesaro stock fell amid a myriad biotech catalysts. On Monday, the 35th annual JPMorgan Healthcare Conference kicked off in San Francisco. Early Wednesday, comments by President-elect Trump regarding drug pricing sent shares into a tailspin.

After two days in the black, biotech stocks toppled 3.1% on Wednesday. But IBD's 420-company Medical-Biomed/Biotech industry group, down more than 2% earlier Thursday, ended the session up a fraction, trading at its 50-day and 200-day moving averages.

Things are looking up for Tesaro, despite the FDA's request for more information into its manufacturing process for IV drug Varubi. Varubi is the brand name for Tesaro's drug to treat delayed nausea and vomiting associated with chemotherapy.

Tesaro said it was forced to find a second manufacturer for Varubi after it identified potential deficiencies at the original manufacturer. The FDA is trying to determine comparability between the products manufactured at both sites.

Credit Suisse analyst Alethia Young called the issue "relatively minor." She has an outperform rating and 151 price target on Tesaro stock, and expects the company to refile with the FDA within the next two months. Approval could come as soon as mid-2017, she said.

"The FDA is not questioning the comparability but looking for more info about actual assay," she wrote in a research report. "Tesaro provided the in vitro release assay as requested, but apparently the FDA has further questions about the assay."

Importantly, there are no safety and efficacy concerns associated with Varubi, Leerink analyst Seamus Fernandez wrote in his research report. Fernandez has an outperform rating on Tesaro stock. He also expects Tesaro to refile later in the first half of 2017.

Assuming a speedy approval process, Fernandez maintains his estimates on Varubi sales at $343 million worldwide in 2026. He expects Varubi to gain 35% share in the U.S. and 25% share in Europe.