Indivior Share Discussion Threads

[tsmith2] 16/7/2018 09:19

Thank you.

[waldron] 16/7/2018 09:07

WELL DONE MR SMITH

[tsmith2] 16/7/2018 08:54

have sold. Good trade.

[waldron] 16/7/2018 08:47

thats a beer for me

what else

cheers

HAVE A GREAT WEEK

SUNNY HERE AGAIN

[waldron] 16/7/2018 08:45

16 July 2018

Indivior Is Granted Preliminary Injunction on Generic (buprenorphine and naloxone)

Sublingual Film

Slough, UK, 16 July 2018 - Indivior PLC (LON: INDV) ("Indivior" or the "Company") announced that the U.S. District Court for the District of New Jersey has granted a preliminary injunction (PI) against Dr. Reddy's Laboratories (DRL). The restrictions of the previously entered temporary restraining order (TRO) remain in place, and DRL is unable to sell, offer to sell, or import its generic buprenorphine/naloxone sublingual film product, pending the outcome of recently filed litigation against DRL related to U.S. Patent No. 9,931,305 (the '305 patent), or a decision of the U.S. Court of Appeals for the Federal Circuit dissolving the injunction. The Court has also ordered the parties to submit a final proposed injunction order on Monday, July 16.

The U.S. District Court for the District of New Jersey has also ordered Indivior to post a bond to provide security to DRL should the court conclude at the end of patent litigation that the '305 patent is invalid and/or not infringed. The bond amount will be determined by the court at a later date.

As noted in the press releases Indivior published on June 15th and July 11th, DRL sold a quantity of its generic buprenorphine/naloxone sublingual film into the U.S. market prior to the granting of a temporary restraining order (TRO) on 15th June. Indivior does not know the exact quantity of product sold by DRL prior to the issuance of the TRO, but based on the recent abrupt loss of market share for its SUBOXONE(R) Film, anticipates the FY 2018 net revenue impact to be at least $25m. Reflecting this and other U.S. market developments, Indivior noted that its FY 2018 financial guidance is no longer valid and that it cannot reliably provide updated FY 2018 net revenue and adjusted net income guidance until the impact of DRL's launch is better understood. The Company expects that this will be no later than its third quarter results announcement, currently scheduled for November 1st.

Shaun Thaxter, CEO of Indivior, said:

"As a result of the July 13th court ruling, Dr. Reddy's is prevented from re-launching its generic product until the patent litigation related to the '305 patent is concluded or until DRL prevails on an appeal of this injunction. While we do not know the timing for these events, we will continue to vigorously defend our intellectual property.

It is important to recognize that the court's decision does not prevent patients or payors from accessing existing generic sublingual buprenorphine/naloxone medications, as all currently available treatments are unaffected by today's ruling. The U.S. market for medication-assisted treatment is already highly competitive with multiple therapies available, over half of which are generic medicines.

However, patients can face other challenges accessing treatment-such as difficulty finding a treatment provider or dealing with the stigma associated with addiction. Indivior will continue to advocate for broader access to medication-assisted treatment in appropriate forums and remains committed to addressing these challenges through public policy and education efforts.

Protecting the integrity of our intellectual property is fundamental to our ability to deliver our Vision that all patients around the world have access to evidence-based treatment for addiction and its co-occurring disorders. For more than 20 years, we have worked together with stakeholders to educate on the disease of opioid addiction, advocate for access to evidence-based treatment, and progress our pipeline of innovative treatments for substance use disorders (SUD).

SUBLOCADE(TM) (buprenorphine extended-release) injection, our latest innovative treatment, is a once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder. SUBLOCADE(TM) is an important scientific innovation and testament to our focus on understanding patients' unmet needs and accelerating the development of new medications."

[tsmith2] 14/7/2018 16:40

Yes, would think so..big blue day too..

[gregmorg] 14/7/2018 13:05

Yup . Guess the RNS appears first thing Monday

[gambo555] 14/7/2018 11:24

Injunction granted subject to appeal or hearing...good news

[tsmith2] 13/7/2018 23:56

Reads like a v good result for the company..

[tsmith2] 13/7/2018 18:38

When is the judgement due?

[tsmith2] 13/7/2018 17:47

And again today

[steeplejack] 13/7/2018 16:03

Standard life upped its interest by 1.39% when the price fell on Wednesday.Interesting vote of confidence.

[tanelorn] 12/7/2018 17:43

Two interesting reports in the Times, the gist, that it's a roller-coaster, but the main reason for the fall being the lack of take-up on their new injectable monthly substitute.

[steeplejack] 12/7/2018 16:03

Good recovery today,hope this presages a favourable court review.

Plus...
Indivior got a boost as Bank of America Merrill Lynch upgraded the stock to 'buy' following recent share price weakness.

[tsmith2] 11/7/2018 16:24

With the accentuated short position...also brokers seem to have taken worst case scenario..

[steeplejack] 11/7/2018 15:37

The shorts have been systematically upping their interest in the last month and those institutions are based in the USA.They've got a handle on things stateside,feedback from doctors etc and probably got the nod that Dr Reddy had distributed a whole lot of generic that was unknown to the likes of us here.If the court uphold the injunction on Friday,then something around 320p is possible but to go back to the 350p level is asking a lot given the Sublocade news today.This is a wild ride.Actually,a complete lottery at times.

[tsmith2] 11/7/2018 14:21

price falls when shorts increase...which explains the fall earlier...do they keep increasing..?it then works the other way too...

[tanelorn] 11/7/2018 13:13

tsmith2 > If injunction granted £3.5 plus open,

Absolutely agree, indeed much higher.

Nonetheless shorts are increasing....

[tsmith2] 11/7/2018 12:17

If injunction granted £3.5 plus open

[tsmith2] 11/7/2018 12:13

worse case scenario seems to now have been priced inGone long at 253

[steeplejack] 11/7/2018 11:30

Hi Greg.I just wonder if the whole concern about opioid addiction isn't (with presidential blessing) encouraging generic competitors to go ahead and launch,patent rulings be damned.We always knew that Suboxone was under increasing pressure but suddenly the dam looks to have burst.I presume that a court injunction will be effective.Even if the opioid treatment market is flooded with a cheap generic for a short time,it will probably encourage the idea that such availability should become the norm,public interest etc.What concerns me is Sublocade,looks like its got of touch of the Varithenas!Thats a near halving of short term revenue expectation.