Farmas USA

Si es verdad que suben esto, haré un bonito sell the news sin dudarlo...

Alexion's long-acting PNH candidate ALXN1210 on par with Soliris in late-stage study; shares up 11% premarket

https://seekingalpha.com/news/3339413-alexions-long-acting-pnh-candidate-alxn1210-par-soliris-late-stage-study-shares-11-percent

Buenas !! Como la veis ? baja a precios de rebote
FPRX

Muy bonito: había puesta la orden en $138... y ha llegado a $137.8 (ahora ha retrocedido hasta $133)

ALXN

MLNT

¿Ande andas, churri?

Va resumen (largo) de MLNT de la transcripción.

A comentar:

- lo que llevaban de CEM:

• solicitromicina todo detenido
• el ácido fusílico seguirá funcionando solo a través del partner japonés. Si los BARDA les dan algo igual siguen con ensayo; si no, no le meten ni un duro

- lo suyo va bien, pero todo con su debida calma

- van a necesitar pasta en nada

- parece que van a presentar bastante cosa para el ECCMID (European Congress of Clinical Microbiology 21-24 de abril)

-> ergo puede ser momento de entrada ahora y salida en cuanto salgan esos abstracts, que probablemente aprovechen para diluir. También hay presentación el 27 de marzo en la Needham & Company’s 17th Annual Healthcare Conference in New York, a las 12:45pm

ER

first earnings call as a publicly traded company, and due to our recent transactions, the financial results for this quarter do not yet reflect a pro forma company

integration almost complete, we have four products on the market and an industry-leading team to execute our strategy.

last few months: U.S. launches of our two leading products, Vabomere and Baxdela; a regulatory filing submitted in Europe for delafloxacin; the first of many ex-U.S. marketing authorizations submitted in Latin America; and continued productivity from our proprietary Discovery engine

Minocin and Orbactiv, that have both been on the market for a few years, experienced double-digit growth fourth quarter versus third quarter of 2017.

Baxdela It's the only approved quinolone that covers MRSA. This important feature combined with its fixed-dose, lack of significant drug interactions, and interchangeable IV and oral dosage forms, bring a new monotherapy treatment for serious skin infections that we believe addresses important unmet needs of this market. is a fixed-dose IV/oral monotherapy agent. a new fixed-dose quinolone that covers MRSA with basically no drug to drug interactions offers an advancement of the class. we priced the oral form lower than the IV to minimize any disincentive to step down the oral therapy while the patient is in the hospital. the market for Baxdela in scan is large with over 3 million patients hospitalized each year and about 2 million more treated in the emergency department. In addition, there is significant opportunity in the non-hospital settings that surround the hospital. We have over 70 hospitals that have initiated the access or approval process, with many additional reviews scheduled over the coming months.  we have a single Phase 3 in CABP that is greater than 75% enrolled and we expect our last patients to be enrolled later in 2018.We'll complete the CABP study and likely have a readout by early 2019. Sin embargo, at least six months or so before any real traction happens

Vabomere is indicated for complicated urinary tract infections and was developed to target Gram-negative bacteria that produce beta-lactamase enzymes, particularly the KPC enzyme. Now utilizing the market-leading carbapenem, meropenem, we have combined it with a novel BLI, vaborbactam, to offer a treatment specifically designed to address the urgent unmet need of KPC-mediated resistance. It's a fixed-dose therapy with meropenem as the backbone, and importantly, it has a similar safety profile to meropenem alone. Now we have strong supportive data in TANGO-2, the first and only supportive study as monotherapy in CRE, and we are currently working with the FDA on next steps regarding this data. we are evaluating the European market opportunity with the potential for an EMA approval later this year-> la presentación

Now Orbactiv is a long-acting IV single-dose infusion for known or highly-suspected Gram-positive infections with or without MRSA. And finally we round out our portfolio with Minocin for injection, which is one of the few agents approved for the treatment of Acinetobacter. These infections are generally seen in the ICU

So, we have four approved products and an experienced team of over 300 colleagues.We have 135 sales territories and 18 medical science liaisons. We now have the infrastructure in place to develop, market, and promote both our current portfolio as well as any additional assets that we may choose to add.

At Melinta, we don't want to be the largest anti-infective company, but we do want to be the best. There is a profound unmet need that will continue to expand over the next decade around multi-drug resistant bacteria. A great majority of our team has many years of both hospital and anti-infective experience, leading to discovery, development, and commercialization of some of the most impactful antibiotics ever launched.

 

We have support from government agencies for discovery and development of anti-infectives, but at the same time there is a lack of confidence from the market and the ability of antibiotic companies to be successful. it's not that the launches weren't successful, it's that the expectation set were unreasonable in light of the fact that the hospital sale has become increasingly more complex due to multiple stakeholders that may or may not be a part of this mix years ago. We can be very successful and very profitable if we ensure that we are transparent, set our expectations reasonably, manage our financials responsibly, and execute on our focused strategy.

Orbactiv and Minocin, which have been on the market a few years, experienced double-digit growth Q4 over Q3. In fact, the fourth quarter of 2017 was the strongest quarter for these two products combined since their launches, and this all happened in the middle of an integration.

Our partner, Menarini, last week submitted its delafloxacin regulatory filing in the EMA for ABSSSI. our partner in Latin America, Eurofarma, submitted for marketing authorization in Argentina, and these are the first of many anticipated ex-U.S. submissions

inherited programs from the merger with Cempra, solithromycin and fusidic acid: 1 discontinuado; el otro a la espera de ver qué dicen de los BARDA

• Phase 2 study of fusidic acid: single-arm study of 30 patients, clinical success was seen in about 60% of the patients after six months of treatment. well tolerated but resistances developed in some patients with this long-term use. as monotherapy for bone and joint infections at this time
• solithromycin: the safety study required by the FDA for CABP will cost in excess of $140 million between study and post-marketing requirements. We stated previously that we would only explore path forward in the U.S. if non-dilutive funding was available. Now if non-dilutive funding is not available, we will likely evaluate the rationale for continuation of the separate pediatric study, which is currently ongoing and funded by BARDA. We have a meeting scheduled with BARDA in the coming weeks to discuss some of these options.

Our partner, Toyama, is continuing its efforts to develop solithromycin in Japan and we are fully supportive. There are four studies for which enrollment is complete. They are going to run it, commercialize it, and do their things in Japan, and we receive a royalty stream back

30 planned publications in the coming year. Varios saldrán para el ECCMID (European Congress of Clinical Microbiology 21-24 de abril)

current opportunities and early developments, including Radezolid through a partner in Phase 2 and our ESKAPE program of potential new class of medicines targeting the most highly resistant pathogens. We have an active discovery program from which multiple leads are being evaluated as candidates for multiple target product profiles, with the goal of initiating IND-enabling studies in the next 12 months

Pasta:

Melinta had full year 2017 revenues of $34 million, primarily derived from the agreement we entered into with Menarini for approximately 70 countries outside the United States, representing the upfront payment of approximately $20 million and ongoing cost-sharing revenue related to the Baxdela CABP trial. We ended the year with a cash balance of $128 million

We also have remaining debt capacity under the Deerfield agreement, the majority of which we can access after we have achieved a specific historical sales run rate. In addition, we recently filed the universal shelf registration statement with the SEC, which will allow us to provide timely and efficient access to the capital markets, should we decide to issue securities. revenue from our four products, cost reimbursement from our collaboration with Menarini, and milestone achievements for our collaborations with Menarini and Eurofarma.

the vast majority of recent antibiotics have had a relatively slow uptake the first year of launch, most achieving $20 million or less. Vabomere and Baxdela will generate moderate but growing sales, given they are both still in the early launch phase. Orbactiv and Minocin achieved net sales of approximately $34 million for the full year 2017 under The Medicines Company ownership, and we expect high single-digit to potentially double-digit growth to continue in 2018 for these two products. Cost reimbursement relating to the CABP trial collaboration with Menarini will continue until the study completes later this year.

we anticipate total operating expenses including R&D and SG&A for 2018 to be in the range of $175 million to $200 million. This includes research and development expenses.

Q&A: The $175 million to $200 million represents our operating expenses only. excludes investments we would make in future year inventory, and really investments that we are making to improve our manufacturing process going forward. So there would be some -> additional cash burn on top of the $175 million to $200 million . in 2020 we'll have quarters that turn cash flow positive, not necessarily that the full year will be cash flow positive

https://seekingalpha.com/article/4156056-melinta-therapeutics-mlnt-ceo-dan-wechsler-q4-2017-results-earnings-call-transcript?page=12

Diapos:

https://seekingalpha.com/article/4156058-melinta-therapeutics-2017-q4-results-earnings-call-slides

 

No jodas orex?? Si la van a liquidar...

Juas, que estás respondiendo al primer post del hilo, allá por el 2012. XDDDD

MLNT

Pues haber que pasa???

500 cromos más a 10.50

ja,ja esa es buena Tutamen!!

:))))