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Cempra Inc Message Board

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  • Today the FDA approved labeling changes to warn on use of all Flouroquinolones which include levaquin, cipro and avelox (moxifloxacin the drug Cempra went up against in trials)

  • Reply to

    CEMP is the truth and future of the medical world.

    by yahhho123 Mar 29, 2016 10:33 AM

    Huh? I... what?... How... I just... "ABX are the main source of all other drugs." Ummm no. Also: "by adding or deleting/modifying a couple of molecules." Your HO clearly does not understand the basic science behind solithromycin / molecular chemistry. They are not adding or deleting/modifying a couple of molecules to create a new drug. (In a way they are modifying a (singular) molecule, but not really). Prabha often says 'we changed this and added that' to get solithromycin. This is oversimplification for the sake of investment firms, it should be not be taken as the scientific process. First, they aren't adding or deleting molecules. They are choosing chemistries that add different 'functional groups.' A few examples of the functional groups (FGs) that differentiate soli from other macrolides: an FG could be an atom (i.e. F), a small molecule like an amine (-NH2), or a larger structure like aminophenyl triazole. So, they are starting with the macrocyclic lactone ring and modifying the functional groups of that.

    Also, the choice of which functional groups go where is somewhat arbitrary. Solithromycin was not discovered by Cempra. It was discovered by Optimer, which was acquired by Cubist, and subsequently Merck. Optimer was busy doing combinatorial chemistry to see what kinds of macrolides they could develop and patent. The resultant molecules would then be screened for some sort of abx activity. For every molecule that worked there were probably thousands that did not. In a way it is like hunting by walking up to a big tree that looks like something might be living in it, shooting into the canopy, and seeing if anything falls out. Cempra bought a macrolide library from them consisting of 500 probable ABX candidates and after screening them decided that Cem-101 would most likely be successful.
    So in a very real sense, Cempra got lucky. Prabha's knowledge certainly helped, but they still got lucky.

  • Longs will stop at nothing to pump this stock. I mean, successful clinical trials? What's next, FDA approval? A European partner? Keep reaching for straws, longs! ;)

  • Conclusions, Applications, and Future Research Directions

    We believe solithromycin has exciting potential for the treatment of intrauterine infections, prevention of preterm birth, and also treatment of perinatal and postnatal infections. Its pharmacodynamic and pharmacokinetic properties are ideally suited to these applications, and our data on transplacental passage and AF accumulation suggest that this antibiotic may represent a major advance in antimicrobial therapy in pregnancy.

    There are three main obstetric scenarios where solithromycin therapy may be particularly beneficial. The first is in the prophylactic treatment of asymptomatic women at high risk of preterm birth in the first half of pregnancy. The strategy requires the ability to identify women who are at risk of intrauterine infection and, thus, target them for solithromycin treatment (35). Prognostic indications, in addition to standard clinical risk factors, could be abnormal vaginal microbiota or presence of particular microbial profiles or species (15, 16, 111–113), or a short cervix with evidence of inflammatory changes (114–116). The second situation is in women with PPROM. In these pregnancies, macrolides have been shown to have significant benefits in terms of neonatal outcomes (117); with its far superior efficacy profile and ability to treat the fetus in utero, it is likely that solithromycin would be much more beneficial than erythromycin for this indication. Finally, solithromycin may be effective in improving neonatal outcomes in women presenting with preterm labor and intact membranes, providing both antimicrobial and anti-inflammatory benefits to the fetus prior to delivery. In all of these scenarios, co-administration with a more potent anti-inflammatory agent may further improve outcomes. Clinical trials to explore all of these applications are warranted, once pharmacokinetic studies have been conducted to establish safe and effective dosing regimens in early, mid, and late pregnancy. Assessment of the short- and long-term effects of antenatal solithromycin therapy on the vaginal, gastrointestinal, and neonatal microbiomes would also be warranted prior to trials of its therapeutic effectiveness in pregnancy.

  • jhallockmerkle@gmail.com by jhallockmerkle Jun 16, 2016 9:11 PM Flag

    Fernandes is the real deal. Those who say differently have not invested in a successful biotech company

  • Reply to

    Congrats CEMP!

    by golongin2008 May 1, 2016 7:28 PM

    They will. Solithromycin is fantastic against Neisseria. See the ASM publication stating "solithromycin had superior activity against gonococcal isolates compared to activities of azithromycin, other macrolides, and many other classes of antimicrobials". Look at the data in that paper. This small molecule has incredible MICs, sub ug/ul even. It's twice as potent in vitro as Azithromycin in that model. And the resistance pattern: ND. Not detected. This will succeed on Gono, dont worry. My own clinical infection control surveillance is showing almost half of isolates from pneumonia are Z-pak "I" or "R" (intermediate or resistant) as in the CLSI model of antibiograms breakpoints and dosage. Plus Z is completely coming off IP protection worldwide and Pfizer needs a replacement. Why not just grab this is put it directly in their product stream as a replacement, and with the extra GAIN 5 years of product life? It's a no brainer for M and A activity. You've got a layup for one of the worlds oldest successful ABX ever, 600MM per year plus, now in Soli with the additional indications, way over a BB per year. What's not to like? Thanks

  • Reply to

    Anyone think this is a good buy now

    by ashjames408 Jun 3, 2016 10:51 AM

    It all depends. Do you want to use it to send your kids to college in 15 years or do you want to make a quick buck?

    If you are looking for a quick buck then no. It is too volatile right now. There will be some news that is misinterpreted / misrepresented that will send it back to 15 for a few days/weeks between now and August-October. My guess is it will be the Gono results. Don't get me wrong, the results will be and show that Soli works, but the raw data won't show '100% cure.' The data won't be able to disambiguate between incomplete eradication of Gono and a new infection from a new source. Prabha will say that 'if we remove suspected and known incidences of reinfection we achieved 100% cure.' That is good enough for me, but shorts will start twisting it up and try to argue that Cempra is hiding something or use it as evidence that Soli doesn't work as well as is claimed.

    Now, if your timeline is 2+ years, 18 is certainly a buy. Heck, it is even a buy if you want to see a return by Dec. 25th. Once FDA approval comes through there will be a nice bump. If a buyout is announced after FDA approval (which is what happened with Cubist) you will definitely double your money from here. I would like to see Cempra go it alone personally. But then again my timeline for return is 2+ years.

    Now, Soli will not be the only drug on the market, but they will have a 2-3 year head start on the other next generation antibiotics. So, you will just need to time your exit if you decide Cemp is a long term investment. We will see how widely they try to get label approval for Soli and the efficacy of the alternatives in 2018. I will reevaluate then.

    Sentiment: Strong Buy

  • FDA Drug Information ‏@FDA_Drug_Info · 3h3 hours ago
    New! FDA Drug Safety Podcast on fluoroquinolones http://go.usa.gov/cJt49

    As I understand it, FDA states risks outweigh benefits and such drugs should be taken ONLY if no alternative. Changes to labels are coming...

  • CHAPEL HILL, N.C., May 25, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, is jointly developing solithromycin for the Japanese market in partnership with Toyama Chemical, a subsidiary of FUJIFILM Holdings Corporation. The Japanese market is the second largest antibiotic market in the world with a macrolide market potential of over $450 million.

    A Phase 2, multi-center, randomized, double-blind study has been conducted by Toyama to evaluate the efficacy, safety and pharmacokinetics of solithromycin in Japanese patients. Patients with mild to moderate community-acquired pneumonia (CABP) were randomized at a 2:1 ratio to either oral solithromycin or oral levofloxacin for 5 days. Solithromycin recipients received 800 mg on the first day, either as a single dose (QD group), or as a divided dose (BID group), and 400 mg daily on Days 2-5. Levofloxacin recipients received 500 mg once daily on Days 1-5. The Japanese study was similar in design to the Phase 3 studies conducted by Cempra in CABP in accordance with guidance from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

    Efficacy
    Among 154 enrolled and randomized patients, 135 received at least one dose of study medication, and were confirmed by independent expert physician review to have CABP (the modified ITT population). In the modified ITT population, Test of Cure visit (5-10 days after completion of therapy) success was achieved in 34/44 (77.3%), 32/44 (72.7%), and 29/47 (61.7%) patients in the solithromycin QD and BID and Levofloxacin groups, respectively. In the pre-specified Per Protocol population comprised of those patients meeting key study inclusion and exclusion criteria, success at the Test of Cure visit was achieved in 34/40 (85.0%) in the solithromycin QD group, versus 31/40 (77.5%) in the solithromycin BID group, and 29/43 (67.4%) in the Levofloxacin group.

    Safety
    Overall safety and tolerability was similar in both treatment groups, including hepatic events such as increases in alanine aminotransferase (ALT).

    "I could not be happier to receive the results of this important study completed by our strong partner in Japan; the safety and efficacy outcomes further validate global Phase 3 trial data demonstrating the potential for solithromycin in the treatment of this serious infection," stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "The need for a new treatment for CABP in Japan is great as multidrug resistance to common CABP pathogens such as Mycoplasma and Haemophilus continues to rise, with pneumococcal resistance to older macrolides reaching 88% in Japan. Solithromycin has once again demonstrated robust activity in comparison to a potent fluoroquinolone, levofloxacin, one of the most widely prescribed agents to treat CABP."

    Conference Call and Webcast

    Cempra management will host a Q&A webcast and conference call regarding this announcement at 8:00 a.m. ET tomorrow, May 26, 2016. The live call may be accessed by dialing 877-377-7553 for domestic callers and 253-237-1151 for international callers and using conference number: 21844902. A live webcast of the call will be available from the investor relations sections of the company website at www.cempra.com, and will be archived there for 30 days. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers, or 404-537-3406 for international callers, and entering the conference number: 21844902.

    Sentiment: Strong Buy

  • Reply to

    AH Sales Agreement With Cowen??

    by golongin2008 May 6, 2016 10:10 PM

    I'm not happy about the shelf and the overhang it creates for the stock price but I understand the timing. With the US NDA now filed and the EU filing imminent they're about to commence serious negotiations on an ex-US (and ex-Japan) partnership, and perhaps to listen to overtures for a US partnership or a buyout. To maximize their bargaining power in any partnership or buyout negotiation they have to show they can go it alone if necessary. Having enough cash to last into early 2017 as they currently do doesn't accomplish that. Now they can say they can raise more money IF AND WHEN THEY WANT TO. If they close an ex-US deal on terms that bring in a lot of upfront cash they probably won't draw on the shelf anytime soon, except perhaps opportunistically if the pps rises substantially. If after approval it becomes clear that they really are going to go it alone in the US they'll probably do a raise but we always knew that would happen.

  • Reply to

    What caused the stock to drop in June 2015

    by orgchemsi Jun 27, 2016 4:51 PM

    What are you talking about? June 1st stock was $36 and June 30th stock was at $34????

    Do you mean the spike down in october of 2015? That was because while results were good, they didn't show superiority over moxi in the severely ill, and because of an outcry of Liver function tests.

    1) study was not designed for superiority, and the goal had been noninferiority all along. I was happy with the results, market wanted superior %, even tho that would not have been statistically significant anyway.

    2) Solithromycin had more grade 3 lft elevations than moxi. People went wild over the implications, forgetting to mention that MOXI had more grade 4 elevations than soli.

    3) It was the birth of the biotech bear. Any bio news, regardless of good or bad, the stock would go down. ONCE reported unexpectedly good results and also got beaten down. We are still in the same sort of market that any biotech news outside of buyout means absolutely nothing. Look at GWPH with excellent results and only a modest pps increase.

    No one knows how long the biotech bear will last, but one things for sure; people are idiots and this includes the tutes, insiders, and big pharma. If the "elite" were so omniscient, why were so many analysts putting 220+ pt on BLUE and AZN buying out zs9 at such a high premium? Couldn't someone have warned CELG to wait a few months to buy RCPT? Likewise, no signficant M & A in biotech in 2016 despite repeat ibb $240 bottoms because all of a sudden, big pharma doesn't want to take the "risk". They will be chasing each other hand over fist when the bear biotech market is over, paying double what they could have now. That's how i know the game isn't rigged, it's just fear and emotions eating away at logic.

    Sentiment: Strong Buy

  • John Levin filed that they bought over 40MM worth of stock. This is how the pros accumulate stock, folks

    They use every trick in the book to hold the price down while SMART MONEY buys a truckload of shares.

    Dont let them take yours. That CC was FANTASTIC.

  • I woke up this morning to a buyout of nearly 100% over Friday's close in CPXX. It's going to happen here, as well! Tick tock!!

  • I am such a DB. The last time I was on this board I made the defacto statement that if CEMP closed below $15.50 it would fall to $7 or $8. In reality, I don't have the slightest clue what I'm talking about...honestly, there hasn't been a single thing I've gotten right since I've been on this board. I'm just hoping there are a few new dupes on this board that know nothing of my history and will give some minuscule degree of validation. Anyone? Anyone? Come on, look at my handle...I'm a pro. Anyone?

  • Part. 2

    Long: The body of Merle Haggard was recently exhumed and given a shot of Soli.
    Within 5 minutes he was on the phone to his agent planning his "Merle Haggard:
    Back From The Grave" tour.
    Short: It doesn't matter.

    Long: Cempra signs European and rest of the world, minus the U.S. and Asia, partner
    with excellent milestone and royalty prospects.
    Short: It doesn't matter.

    Long: Soli gets FDA approval.
    Short: It doesn't matter.

    Long: Soli gets EU approval
    Short: It doesn't matter.

    Long: Soli gets Japanese approval.
    Short: It doesn't matter.

    Long: Soli surpasses both company and analyst sales guidlines for the first full
    quarter of reported sales.
    Short: It doesn't matter.

    Long: Anecdotal reports slowly filter in about cases where Soli is working when
    other antibiotics are having great difficulties.
    Short: It doesn't matter.

    Long: Soli is approved for the indication of Gonorrhea.
    Short: It doesn't matter.

    Long: Soli gets Cystic Fibrosis indication approval.
    Short: It doesn't matter.

    Long: Soli gets COPD indication approval.
    Short: It doesn't matter.

    Long: Soli gets NASH indication approval.
    Short: It doesn't matter.

    Long: The U.S. government says it will maintain a stockpile of 5 million doses of
    Soli for use against bioterrorism.
    Short: It doesn't matter.

    Long: Cempra spurns 100% takeover premium in unsolicited offer, telling the would-be
    suitor to "pound sand" because we're worth multiple times that much.
    Short: It doesn't matter.

    Long: The short in this exchange begrudgingly takes Soli to recover from a near death experience when no other antibiotic would work.
    Short: It doesn't matter.
    Long: How can you say it doesn't matter??? Soli just saved your life.
    Short: It doesn't matter because I'm now broke because of my short position in Cempra. I'll probably just max out my credit cards in one last hurrah and then jump out a window anyway.

  • Reply to

    Short interest approaching record levels

    by pharmajedi Mar 30, 2016 6:16 PM

    Love it. The squeeze will be that much bigger.

  • Soli is uninspiring? Me too ABX? Continuing to pound non-inferiority as a negative when it is the standard for trials? Can't you try a little harder? The only thing uninspiring with the Cempra story right now is the audacious continuation of the short thesis.

  • Reply to

    Who created this drug they are trying to sell?

    by bridgejumper08 May 11, 2016 10:05 PM

    The FDA does not agree anymore with you as to the risk of Fluoroquinolones. They did at one time and that is why Cempra chose to use it as a comparator.

    In the near future, it will be very hard to justify using that particular type of ABX as first line choice. They will save it for when the patients life is at risk due to non-response from other first line ABX's. That opens up a place for a new first line ABX that has not had resistance built up to yet.

  • Reply to

    CONT.

    by megfromourterrace May 6, 2016 12:44 PM

    You try so hard to sound genuine. The only problem with your argument is that ALL of biotech is in a bear market, but your arguments make CEMP sound somehow unique. Also, I would love to know in what world drug reps make double what doctors make?

    Cemp is behaving EXACTLY as the rest of the sector is, and no amount of pointing to Management farting at the wrong time, dilution, or the results of the P3 changes that. Everyone knows that when IBB rebounds, so will CEMP. For crying out loud, this thing is trading less than it did before either of the P3 results were out, and we are now passed the NDA stage. Nearly EVERY biotech is trading a lot less than it did from a year ago. So continue to make up a narrative that ignores the biotech bear market if it makes you feel better. It's been bad for about 10 months now; how much longer will it last?:- tick-tock, tick-tock, tick-tock....

    Sentiment: Strong Buy

  • Reply to

    The Street = joke....

    by gilliel7 Jun 6, 2016 12:39 PM

    Agree. TheStreet and the Cramer is a disgrace. They have been discredited for many years. Who buys their service??

    Sentiment: Strong Buy

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